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S1-1
Improving HIV Testing and Receipt of Results by Nurse Rapid Testing and
Streamlined Counseling: A Randomized Controlled Trial
Henry Anaya, PhD1, Steven Asch, MD1, Matthew Goetz, MD2
1
US Department of Veterans Affairs, 2US Department of Veteran's Affairs
Background: The CDC recommends offering HIV tests to those between 13 and 64, yet testing
rates remain low, even among those at risk. Implementing HIV testing into primary care also
poses organizational challenges.
Objective: We tested three methods that have proved effective in other diseases or settings:
nurse standing orders for testing, streamlined counseling, and rapid testing, which allows for
results in 20 minutes.
Design: Randomized, controlled trial with three intervention models: Model A- traditional
counseling and testing; Model B-nurse based screening, traditional counseling and testing; Model
C-nurse-initiated screening with streamlined counseling and rapid testing.
Setting: Two VA clinics in the same city; one at a large urban hospital, one freestanding
outpatient clinic in an area of high HIV prevalence.
Participants: 251 patients with scheduled or walk-in appointments for primary/urgent care.
Measurements: Rates of HIV testing and receipt of results; reduction in sexual risk and
improvement in HIV knowledge.
Limitations:
experience.
Possible control group testing bias; difficulty generalizing from two clinics’
Results: Testing rates were 40.2% for Model A, 84.5% for Model B, and 89.3% for Model C.
Rates of receipt of test results were 14.6% for Model A, 31.0% for Model B, and 79.8% for Model
C. Reduction in sexual risk and improvement in HIV knowledge did not differ significantly
between participants receiving traditional versus streamlined counseling.
Conclusions: Streamlined counseling with rapid testing increased rates of testing and receipt of
results over current practice without any change in post-test knowledge or risk behavior.
Increased rates of testing and receipt of results could lead to earlier disease identification,
increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined
counseling with routine rapid testing when implementing into primary/urgent care clinics.
S1-2
Use of Crack Cocaine Among HIV-Infected Persons is Associated with High
Risk Sexual Activity and Failure to Receive Outpatient HIV Care
Lisa Metsch1, Carlos del Rio2, Allan Rodriguez1, Tanisha Sullivan2, Gabe Cardenas1, Lauren
Gooden1, Margaret Pereyra1, Christine Bell2, Toye Brewer1, Tamy Kuper1, Sarah Lewis3, Richard
Rothenberg2
1
University of Miami Miller School of Medicine, 2Emory University School of Medicine, 3Barry
University
Background: Crack users are at risk for sexual transmission of HIV due to involvement in sex for
crack and money exchanges. Inner city hospitals have a large admission rate of HIV-infected
persons who could be linked to HIV prevention and treatment services.
Methods: Interviews were conducted at bedside with 619 HIV-infected patients deemed mentally
stable, in two inner city hospitals in Miami, FL and Atlanta, GA between April and December of
2006. Logistic regression analysis assessed the association of variables with ever having an HIV
primary care provider (PCP).
Results: The sample was largely male (62.6%), over 40 (71.9%), and African American (81.1%),
and 36.3% used crack in the past 6 months. Crack users were more likely than non-users to be
sexually active (53.8% vs. 33.3%, p<.001), and have unprotected sex with an HIVnegative/unknown partner (12.9% vs. 5.6%, p<.05), but were less likely to have ever had an HIV
PCP (70.1% vs. 82.2%, p<.01) or received HAART (66.7% vs 78.7%, p<.01). In the logistic
regression analysis, crack users had twice the odds of never having an HIV PCP (adjOR = 1.68,
CI 1.07, 2.62) while controlling for other variables.
Conclusions: Over a third of hospitalized HIV patients reported recent crack use. Many of them
are not receiving HAART, have never seen an HIV PCP, and are still engaging in high-risk sex.
The hospital presents an opportunity to identify high risk patients such as crack users who are not
using care and prevention services and to link them to these services.
S1-3
Improving Team Approaches to the Pregnant HIV+ Patient
Marla Shauer, MSN1
1
Womens Services, Washington Hospital Center
A team approach is vital to identification, continuity, and follow-through in Pregnant HIV+ patients.
At Washington Hospital Center (WHC), pregnant patients are initially screened with the opt-out
approach. Known HIV+ patients are referred to WHC from other hospitals and clinics. WHC
performs the largest amount of deliveries annually in the District of Columbia (4,400), and has a
high number of HIV exposed babies born annually (1%). Therefore a team approach is key to
quality care and successful outcomes for mother/neonate. A program has been created to
improve communication between Perinatal and Infectious Disease teams. These teams include
multiple providers; Obstetric Attendings, residents, Infectious Disease Attendings, fellows,
adherence nurses, Social Work (from both departments), as well as a local family-centered care
organization. A nurse midwife facilitates team communication by participating in both ID and
Perinatal High Risk rounds. As pregnancy is an opportune time to access medical care, education
during prenatal care is thorough, frequent, and supportive. Issues of partner disclosure and
maternal knowledge gaining of HIV in pregnancy are frequent challenges. Another issue is the
timeliness of coordinating care between departments in pregnancy. The team is attempting to
improve access to ID care in a timely manner, and is often accomplished by ID Attendings
consulting. With growing numbers locally of HIV, coordinating excellent team care in time to
reach therapeutic goals at delivery remains an integral goal.
S1-4
"HIV Testing in VA Primary Care, Emergency Departments, and Behavioral
Health Clinics: Are Those at Risk Really Being Tested?”
Judy Shaw, MS1
1
Section of Infectious Disease, Samuel S. Stratton VAMC
Presenting Author: Judy K. Shaw, MS, ANP-c
Affiliation: Samuel S. Stratton VAMC
Address: 113 Holland Ave. MC 111D, Albany NY 12208
E mail: [email protected]
Phone: (518) 626-6421
Fax: (518) 626-6564
Background: Studies have shown that opportunities are missed for HIV testing, even with
obvious risk factors. Appropriate testing may decrease the likelihood of the continued spread of
infection.
Method: Lists were obtained from the Microbiology Department of the Stratton VA Hospital for all
persons being tested for HIV, gonorrhea, Chlamydia, syphilis (RPR only), and trichomoniasis, and
from the VA information system for patients with newly entered ICD-9 codes for hepatitis C
(HCV), cocaine, and heroin use from July 15, 2004 through July 15 2005. A retrospective chart
review was conducted only for patients on the list who had been seen in Primary Care (PC),
Behavioral Health (BH), or the Emergency Department (ED).
Results: Patient risk factors included: syphilis (420), Chlamydia (75), gonorrhea (53),
trichomoniasis (5) (STD= 553), HCV (82), cocaine (50), and heroin use (16) (ICD-9=148). The
majority of patients (N=407) was white (71.3%) PC patients (67%) with a mean age of 58 (R= 72,
SD= 17.57), who had a mean number of clinic visits of 3.14 (R=0- 22, SD= 3.73). Fifty-one
(12.5%) patients were tested for HIV, 2 (0.5%) refused, or testing was considered by the provider
but not ordered (1.5%). Most (87%) were not offered an HIV test. No significant correlations were
identified between being tested for HIV, site of encounter, age, race, or risk factor. Three had
positive HIV test results (0.009%).
Significance: Results of the study will be used to make recommendations to develop prevention
programs for veterans and educational programs for providers and staff.
S1-5
Has Your Partner BeenTested? Counseling and Testing in an HIV Primary
Care Clinic
Stephanie Pons, MSSW1, Eric Anderson, AA1, Lori Fantry, MD1
1
University of Maryland
The Institute of Human Virology of the University of Maryland Medical Center has developed a
counseling and testing site within its primary care clinic, The Evelyn Jordan Center, the hub of
HIV clinical care .We are currently providing medical care and support services to approximately
1800 HIV positive individuals in Baltimore City. The population of the patients served is 81%
African American, 33 % women and 50% are past or current substance abusers. Over the years
we have encouraged our patients to have their partner tested for HIV, however it was necessary
to refer them to outside testing centers. In 2006, we implemented our own test clinic targeting the
partners, family and friends of our HIV positive patients.
HIV rapid testing in an HIV primary care setting ensures immediate access to HIV medical care
and related support services. Our experience has show that it increases an individual’s
willingness to get tested, adherence to medical care, and ability to cope with their diagnosis.
Additionally, the individuals who are referred for testing through social networking including
partners, friends or family members who are HIV positive, are likely to receive added emotional
support and transmission education, resulting in improved adherence to care. This poster
describes the implementation of the project, and challenges met along the way. Suggestions to
others who are planning a testing clinic within a primary care setting will be addressed with
specific recommendations. Further research is indicated to analyze seropositivity rates among
our population.
Disclosure: This project was supported through an unrestricted grant provided by Gilead
Sciences.
S1-6
Engaging Hospitals to Reduce Prenatal HIV Transmission: HIV Rapid
Testing in L & D (RTLD)
Carolyn Burr, PhD1, Margaret Lampe, MPH2, Elaine Gross, MS1, Jill Clark, MPH2, Rhondette
Jones, MPH2
1
François-Xavier Bagnoud Center, UMDNJ, 2Division of HIV/AIDS Prevention, U.S. Centers for
Disease Control and Prevention
Problem: Women may not be offered or may refuse prenatal HIV testing or may not access
prenatal care. For women presenting in labor with undocumented HIV status, rapid HIV testing
can reduce the risk of prenatal HIV transmission and engage women with HIV care. Further,
hospitals may be unaware of their role in reducing prenatal HIV transmission.
Methods: 8 regional strategic planning workshops designed to increase the number of hospitals
offering RTLD were held though out the U.S. 70 hospital teams from 28 states/territories
participated. Hospitals sent leaders from obstetrics, nursing, laboratory and administration to
workshops which provided current scientific information on RTLD, helped to build skills, and
facilitated the development of individualized action plans. Follow-up evaluation consisted of an
interview regarding progress toward providing RTLD.
Results: 48 (69%) hospitals were interviewed 9 -15 months following the workshops; 40 (83%)
were offering RTLD (35 had policies in place or in process) and 2 (4%) offered expedited ELISA.
Barriers to policy development included administrative hurdles and knowledge/attitudes of
physician and nursing staff. Keys to implementation included a multidisciplinary team approach,
education of hospital staff, a “champion,” and laboratory support.
Conclusion: Strategic planning workshops were effective in building hospitals' capacity to offer
RTLD by engaging key leaders, providing a scientific foundation for policy change, and facilitating
planning by hospital teams. Strengthening hospitals' capacity fosters the goals of universal HIV
testing for pregnant women, engaging women with HIV in care, and further reducing perinatal HIV
transmission.
S1-7
Use of iMedConsent to Implement Routine HIV Testing at a VA Medical
Center
Beverly VanMetre, MS1
1
VA Medical Center Martinsburg, WV, Department of Veterans Affairs
Background and Purpose: Making HIV testing a routine part of medical care has been endorsed
by CDC and VA to encourage early diagnosis of HIV infection thereby preventing morbidity and
mortality associated with late diagnosis and improving prevention outcomes. CDC no longer
recommends separate written consent for HIV testing, however, VA providers must continue to
adhere to current federal law which requires separate written consent and pre-and post-test
counseling for HIV testing performed in VA facilities. Using paper consent forms is cumbersome,
time-consuming and necessitates scanning of the completed document into VA’s electronic
medical record. This constitutes a barrier to providers having routine discussions about HIV
testing with their patients.
VA’s Computerized Patient Record System incorporates iMedConsent™, a comprehensive,
computer-based informed consent application. HIV consent is one of the choices in this software
package. When completed using an electronic signature pad, the application automatically
populates a progress note and stores an electronic image of the signed informed consent in the
patient’s electronic medical record.
Method: In August 2006, providers in the medical clinic which serves the homeless veteran,
PTSD and addiction residential treatment programs agreed to begin offering HIV testing to all
patients at time of admission utilizing iMedConsent™.
Findings: Rate of HIV testing for the 1st quarter FY ’07 increased by 97% when compared to the
1st quarter FY ’06.
Implications and Next Steps: Utilizing electronic informed consent minimized a barrier to
providers offering HIV testing in one care setting. We are in the process of implementing
iMedConsent™ for HIV testing in primary care clinics.
S1-8
Point of Care HIV Testing
Nicole Dolder, PharmD1, Dianne Griffin, RN2, Beth Smith, RN2, Charles DeComarmond, MD2
1
Pharmacy, VA Salisbury, 2Infectious Disease, VA Salisbury
On December 1st, 2006, in honor of World AIDS Day, the VA Salisbury Infectious Disease Clinic
implemented the use of OraQuick ADVANCE Rapid HIV-1/2 Antibody Testing. Patients are now
able to receive HIV testing on a walk-in basis in a matter of minutes. Pre-counseling is performed
with IMED consent by infectious disease nursing and pharmacist staff, which allows for electronic
documentation of consent. Patients rub the test device between their lip and gumline. Test
results are available within 20 minutes and post-counseling is performed immediately. Nonreactive test results are given by infectious disease clinic nursing and pharmacist staff, while
reactive test results are given by the infectious disease physician. The test is assigned an
accession number and data is input into the laboratory package in the VA VISTA computer
system. This allows for the test results to be immediately displayed in the computerized patient
record system (CPRS). The implementation of this quick testing process has been user friendly
and well accepted.
S1-9
STORMS: Studying Trends of Recent Major Storms
David Little, MS1
1
South Alabama Cares
Background: In the wake of the unprecedented hurricane season of 2005, the gulf coast is still in
a recovery phase. Questions have been raised about access to care, continued adherence, and
prevention of HIV infection among those affected by Hurricane Katrina.
Methods: A survey was sent to 3 agencies, South Alabama Cares in Mobile, AL, South
Mississippi AIDS Task Force in Biloxi, MS, and NO AIDS Task Force in New Orleans, LA. Clients
served, HIV tests and HIV positive results were reported. Clients served were best estimates. HIV
tests performed and % of HIV+ were accurate numbers. Comparison was made for 3 months
prior to Katrina and quarterly thereafter for one year.
Results: The Alabama group remained stable and positive tests remained fairly constant. In the
areas hardest hit, there was a greater change in clients served. At 3-6 months post storm there
an increase in percentage of positives in the MS and LA sites. Percent positive tests rose from
11.1% to 28.6% and 3.8% to 4.5% in MS and LA respectively.
Discussion: This study reveals a need to search further into the behaviors and challenges for
those infected with HIV during disasters. More studies are needed regarding risk behaviors,
access to care and medication and prevention preparations for future disasters.
S1-10
Using Statistical Modeling to Improve HIV Casefinding
Allen Gifford, MD1
1
VA New England Healthcare System
There is interest in assembling disease registries with the increasing availability of electronic
medical records. Such registries are useful tools for tracking quality, although generally
dependent upon simple capture rules that use only disease-specific information, which may miss
actual cases. We developed and tested algorithms for identifying HIV-infected persons within the
VA and compared performance to a reference model using only HIV-specific diagnoses.
We built logistic regression (LR), decision tree (DT), and neural network (NN) models in SAS
Enterprise Miner v.5.2 using 123 variables derived from several merged VA databases as inputs
from 4.97 million patients with at least one outpatient or inpatient encounter between 6-1-04 and
5-31-05. Because an even sample of true positives (TPs) and true negatives (TNs) was used in
model development, we incorporated population priors and corresponding decision weights to
achieve conforming population models. Sensitivity analyses were conducted.
All of our models outperformed the reference model (RM). Adjusted false negative (FN) and false
positive (FP) rates were (FN rate/FP rate, number of variables used: Stepwise LR, 0.012/0.717,
19; DT-Boosted, 0.011/1.050, 53; NN-3 neurons, 0.010/1.468, 54, compared to RM, 0.016/0.100,
1. ROC indices for all of our models were significantly better than the RM (p?.05). Demographic,
clinical, and utilization variables were selected.
We demonstrated improved case finding using sophisticated methods compared to a simple
reference model by using additional variables available in VA data. An improved algorithm, in
terms of accuracy and policy priorities, may serve as a practical tool for improving a disease
registry for HIV.
S1-11
Abstract On Cinico-Epidemiological Scoring System
Anuja Bandyopadhyay, MBBS1
1
Medical College, Kolkata
THE USE OF A CLINICO-EPIDEMIOLOGICAL SCORING SYSTEM FOR
EARLY DIAGNOSIS OF PEDIATRIC HIV/AIDS IN INDIA
Introduction: In children HIV presents with a spectrum of manifestations and often goes
undiagnosed. The need arises for a uniform, standardized protocol which would enable not only
the clinicians, but also other health workers to identify the population to be screened for HIV. The
aim of this study was to establish whether a scoring system, devised in Medical College, Kolkata
could be used in the out-patient department.
Methodology: 400 patients attending the pediatric outdoor patient department in Medical College,
Kolkata for the first time were examined by the attending physician and the clinical impression
noted. At the end of the examination, a questionnaire, based on the scoring system was filled up
for each of the subjects. Each patient was scored. ELISA test was performed. The results of the
diagnostic tests were correlated with the clinical impression of the physician and the scoring
obtained.
Results: Through a R.O.C. curve analysis, we determined the cut-off value of the scoring system
to be >9, giving equal weight age to sensitivity and specificity. In our study, the sensitivity and
specificity of such a scoring system was found to be 95.65% and 98.6% respectively. When
comparing the diagnostic odds ratio of such a scoring system (1373.564676) with that of clinical
suspicion (42.279996), we found the scoring to be superior.
Conclusion: In the background of our resource-limited settings, this clinico-epidemiological
scoring to identify the HIV positive patients in out-patient department or field would be a more
accurate means of screening, particularly after taking 9 as the cut-off value.
S2-1
Evaluation of CD8+ T-cell And Antibody Responses Following Transient
Increased Viraemia in Sooty Mangabeys Infected With Live, Attenuated
Simian Immunodeficiency Virus
Evaluation of CD8+ T-cell and antibody responses following transient increased viraemia in sooty
mangabeys infected with live, attenuated simian immunodeficiency virus.
Abstract presenter: A.U.UMURHURHU
Co-authors:
I.B.IBIANG; E.A.ONOIGBORIA; S.I.GUNAID;V.I.OFARN.
Department:
virology department,
LAGOS UNIVERSITY TEACHING HOSPITAL(LUTH)
SCHOOL OF MEDICAL LABORATORY SCIENCES.
IDI-ARABA, LAGOS,NIGERIA.
POSTAL CODE: 234
In vivo depletion of CD8+ T cells results in an increase in viral load in sooty mangabeys
chronically infected with simian immunodeficiency virus (SIVmac239nef). Here, the cellular and
humoral immune responses associated with this transient period of enhanced viraemia in
mangabeys infected with SIVmac239nef were characterized. Fourteen days after in vivo CD8+ Tcell depletion, two of six mangabeys experienced a 1–2 log10 increase in anti-gp130 and p27
antibody titres and a three- to fivefold increase in gamma interferon-secreting SIV-specific CD8+
T cells. Three other mangabeys had modest or no increase in anti-gp130 antibodies and
significantly lower titres of anti-p27 antibodies, with minimal induction of functional CD8+ T cells.
Four of the five CD8-depleted mangabeys experienced an increase in neutralizing antibody titres
to SIVmac239. Induction of SIV-specific immune responses was associated with increases in
CD8+ T-cell proliferation and fluctuations in the levels of signal-joint T-cell receptor excision
circles in peripheral blood cells. Five months after CD8+ T-cell depletion, only the two highresponding mangabeys were protected from intravenous challenge with pathogenic SIV, whilst
the remaining animals were unable to control replication of the challenge virus. Together, these
findings suggest that a transient period of enhanced antigenaemia during chronic SIV infection
may serve to augment virus-specific immunity in some, but not all, mangabeys. These findings
have relevance for induction of human immunodeficiency virus (HIV)-specific immune responses
during prophylactic and therapeutic vaccination and for immunological evaluation of structured
treatment interruptions in patients chronically infected with HIV-1.
AMO-AV-19701.
K. A. Reimann, R. A. Parker, M. S. Seaman, K. Beaudry, M. Beddall, L. Peterson, K. C. Williams,
R. S. Veazey, D. C. Montefiori, J. R. Mascola, G. J. Nabel, and N. L. Letvin
S2-2
Efficacy of Tenofovir-Emtricitabine and Boosted Atazanavir Combination in
the Treatment of HIV- Infected Patients Naïve to Antiretroviral Therapy
Catherine Chien, MD1, Homayoon Khanlou, MD1, Marjan Javanbakht, PhD2, Paul DenOuden,
MD1, Parveen Kaur, MD1, Alen Voskanian, MD1, Charles Farthing, MD1
1
Medicine, AIDS Healthcare Foundation, 2Epidemiology, Univercity of California at Los Angeles
Background: Clinical information is lacking regarding the efficacy of tenofovir (TDF) and
emtricitabine (FTC) in combination with boosted atazanavir (ATV/r) in the treatment of
antiretroviral naïve patients.
Methods: We undertook a retrospective analysis of all patients naïve to antiretroviral therapy who
started treatment with ATV/r+TDF+FTC and compared them to those who started with TDF+FTC
and a non-nucleoside reverse transcriptase inhibitor (NNRTI): efavirenz or nevirapine. Patients
were included if they had a self-assessed adherence score of >95% and had at least 12 months
of follow-up. The HIV-1 RNA levels and CD4 counts were compared at baseline and at 6 and 12
months.
Results: Forty-four patients in ATV/r group and 63 patients in NNRTI group (EFV:48; NVP:15)
were identified. The baseline median HIV-1 RNA and CD4 counts were 4.96 log10 and 213
cells/mm3 (1-500) in the ATV/r group compared to 4.86 log10 and 239 cells/mm3 (3-945) in the
NNRTI group. Six- and twelve-month data are summarized below.
CD4BL
CD424WK
CD448 WK
VL BL
<50cp/ml
<50cp/ml
24 WK
48 WK
ATV/r arm
213
369
414
4.96
log10
52%
68%
NNRTI arm
239
394
464
4.86
log10
62%
79%
0.32
0.19
p-value
(MantelHaenszel
Chisquare)
Conclusion: Results from this clinical cohort revealed equivalent rates of immunologic and
antiviral efficacy for the two treatment groups. There was a trend, however, toward a greater
proportion of patients in the NNRTI-based treatment group achieving HIV-1 viral load <50
copies/mL at 12 months.
S2-3
Host-Driven Clearance of HIV Infection without Antiretroviral Therapy
Diana Lin, MPH1, Swati Rao, MD1, Ashwani K. Singal, MD1, Meenakshi Zaidi, MD1, Pooja
Motwani, MD1, Samia Ahmed, MD1, Truptesh H. Kothari, MD1, Aelaf Worku, MD1, Norbert Brau,
MD1
1
I.D. Section, Bronx VA Medical Center
Background: Anecdotes of HIV-seropositive patients with undetectable HIV RNA despite lack of
any antiretroviral therapy have long been traded among clinicians. However, no publications
exist on the characteristics or prevalence rates of this population.
Methods: Among 2,165 HIV-seropositive patients (both EIA and Western blot) entered
prospectively into HIV registry of a single tertiary-care center from 1986 – 2005, 119 randomly
selected subjects with available HIV RNA data were retrospectively analyzed.
Results: Cases of host-driven HIV clearance were defined as all plasma HIV RNA tests being
undetectable and the patient never being treated with any antiretroviral medication or with drugs
with anti-HIV activity, such as interferon-alfa. Among the 119 patients, 4 met the criteria of hostdriven clearance (prevalence, 3.36%; 95% confidence interval, 0.095% to 6.63%). The lowest
immunological parameters in this group were a CD4+ count of 500 per mm3, a CD4+ percentage
of 28%, and a CD4/CD8 ratio of 0.78.
Conclusion: Persons who become infected with HIV but clear the infection by virtue of their host
response system are not uncommon. Their prevalence in this small study was 1 in 30. The study
is ongoing and will later present data from a much larger sample size.
S2-4
Newly Diagnosed HIV Infection in the Era of HAART: Age, Survival, and
Serum Markers
VijayLaxmi Misra, MD1, Zeenat Naqvi, MD1, John Eng, MD2, Julie Williams, RN1, Sheldon T.
Brown, MD1, Norbert Brau, MD1
1
I.D. Section, Bronx VA Medical Center, 2Medical Program, Bronx VA Medical Center
Background: HIV infection often is diagnosed only after symptoms occur. This retrospective
study tested the hypothesis that 3 serum markers can predict newly diagnosed HIV-infection.
Methods: From 1997–2002, 112 patients with newly-diagnosed HIV-infection were analyzed for
demographics, mortality, and the serum markers total globulin (= total protein–albumin) and
antibodies to hepatitis B (anti-HBc) and C viruses (anti-HCV). These markers were compared to
all 2,469 patients who tested HIV[-] during that period.
Results: From 1997–99 to 2000–02, mean age increased by 5 years (49.5 vs. 54.5 years,
p=0.021), and mean survival declined (5.4 vs. 2.6 years, p=0.031, log-rank). This decline of
survival was explained by the concurring increase in age; only age >50 years was independently
associated with survival (HR, 0.40, 95% CI, 0.16–0.96, p=0.043). The mean calculated globulin
level was higher in HIV[+] (4.82 g/dl) than in HIV[-] patients (3.38 g/dl, p<0.001). The
corresponding area under the Receiver-Operating-Characteristics curve (AUROC) was 0.888
(95% CI, 0.86 – 0.92). A globulin level of ¬>3.40 g/dL predicted new HIV diagnosis with a
sensitivity of 96.4% and a specificity of 57.6%. Being anti-HBc[+] was predictive of new HIV
diagnosis with a sensitivity of 69.9% and a specificity of 53.3% (p<0.001), but being anti-HCV[+]
was not (p=0.14).
Conclusion: Diagnosis of HIV infection in the era of HAART increasingly occurs at a higher age,
and this trend has led to a higher mortality since 2000. The serum markers globulin level >3.40
g/dL and anti-HBc[+] are associated with a new HIV diagnosis.
S2-5
Limitations in Predicting HIV-1 Co-receptor Tropism from V3 Genotype
Data
ERIC STAWISKI1, STACI BUSH1, LIU YANG1, JON TOMA1, WEI HUANG1, SIGNE FRANSEN1,
JEANNETTE WHITCOMB1, EOIN COAKLEY1, NEIL PARKIN1, SUSAN ESHLEMAN2, CHRIS
PETROPOULOS1, COLOMBE CHAPPEY1
1
MONOGRAM BIOSCIENCES, 2Pathology, JOHN HOPKINS UNIVERSITY SCHOOL OF
MEDICINE
Background: The 11/25 Charge Rule, Decision Trees, Position Specific Scoring Matrices (PSSM),
and Support Vector Machines (SVM) have previously been used to predict HIV co-receptor
tropism directly from genotype. We investigated how env genotyping challenges, HIV-1 subtype,
and X4 prevalence rates influence prediction of tropism from genotype.
Methods: Three env gene sequence datasets were used comprised of 31 subtype B samples
from chronically infected, 76 subtype B samples, and 69 subtype A or D samples. Phenotypic
tropism for the second and third datasets was measured using the Monogram Co-receptor
Tropism Assay. Published algorithms for predicting tropism from genotypes were implemented.
Results: V3 region sequences from matching population and clone sequences were aligned for
each sample. An average of 4 bases were undetectable per population sequence. An average of
3.3 heterogeneous bases per V3 loop were confirmed by cloned sequences. Positive predictive
values for cross-validated datasets based on phenotype were inversely related to X4 prevalence.
The sensitivity for X4 detection was 52 to 76% for subtype B cloned viruses (n=29) and 20 to
60% in non-subtype B pooled viruses (n=5). A positive correlation was found between logtransformed X4 counts and predicted values from the SVM (R2 = 0.85, p < 0.0001).
Conclusions: V3 sequence data can be used in predicting tropism, however, there are analytical
and technical limitations to this approach to make this technique a diagnostic test with clinical
value. Phenotype assays that directly measure co-receptor usage provide an alternative
approach to analysis. Clinical data is needed for both approaches.
S2-6
Technical Validation Defines the Performance of Monogram’s HIV CoReceptor Tropism Assay
KAY LIMOLI1, STACI BUSH1, JEANNETTE WHITCOMB1, LINDA KISS1, WEI HUANG1, SIGNE
FRANSEN1, JON TOMA1, COLOMBE CHAPPEY1, NEIL PARKIN1, CHRIS PETROPOULOS1
1
MONOGRAM BIOSCIENCES
Background: Monogram’s validated assay for the determination of co-receptor tropism (CRT) is
being used for the selection and monitoring of patients in clinical trials of co-receptor antagonists.
Methods: Recombinant HIV-1 containing a luciferase reporter gene, pseudotyped with patientsample derived envelope (gp160), were generated by transfection of HEK293 cells. CRT was
evaluated by measuring luciferase activity following infection of U87 cells expressing CD4 and
either CCR5 or CXCR4, in the absence and presence of a corresponding co-receptor inhibitor.
Tropism is designated as CCR5-only (R5), CXCR4-only (X4), or dual/mixed (DM).
Results: Monogram’s Co-Receptor Tropism assay accurately measured CRT in a panel of 46 well
characterized HIV-1 strains representing multiple subtypes. In a panel of 3 clonal viruses (R5, X4,
or dual-tropic), all pairwise comparisons (>1000) of within-assay replicates gave concordant
results. Using a panel of 46 R5 or DM patient plasma samples, discordance was limited to 3
samples; these samples produced luciferase signal from CXCR4 cells that approached assay
background. Forty-five of 48 samples with viral loads between 500 and 1000 copies/mL, and 104
of 109 samples with 1000 -10,000 copies/mL, were successfully amplified. Using R5- and X4tropic patient-derived gp160 clones that exhibited similar infectivity for mixing experiments, a 10%
mixture was detected in 100% of 80 assays, and a 5% mixture was detected in 83% of assays.
Conclusions: Monogram’s Co-Receptor Tropism assay is an accurate, precise, sensitive,
reproducible and robust assay for the measurement of HIV-1 CRT and has become the standard
assay for patient screening and monitoring in the development of co-receptor inhibitors.
S3-1
Week 48 Antiretroviral Response to Darunavir (TMC114)/ritonavir and
Etravirine (TMC125) Combination in Patients with High Level Viral
Resistance
Marta Boffito1, Alan Winston1, Akil Jackson1, Carl Fletcher1, Anton Pozniak1, Mark Nelson1,
Graeme Moyle1, Richard Hoetelmans2, Diego Miralles2, Brian Gazzard1
1
Chelsea & Westminster Hospital, 2Tibotec BVBA
Background: The protease inhibitor darunavir has recently been approved for the treatment of
HIV infection, whilst etravirine is an investigational NNRTI; both have shown activity in naïve and
experienced patients. Having previously demonstrated the absence of a clinically significant drug
interaction between these agents, we present 48-week data in 11 HIV-infected patients with
extensive viral resistance.
Methods: Virologically failing HIV-patients with documented three-class resistance were enrolled
into a study to investigate the pharmacokinetics, safety, and efficacy of darunavir/ritonavir
600/100mg twice daily and etravirine 200mg twice daily (new formulation) plus nucleoside
reverse transcriptase inhibitors (NRTI) with or without enfuvirtide (ENF). Genotype and phenotype
testing, safety, and efficacy parameters were assessed at baseline and over the study period.
Results: Eleven patients completed the 48-week study with the following baseline characteristics
{median (range)}: age 45 (39-57) years, CD4 100 (3-490)cells/mm3, viral load (VL) 4.9 (3.9-5.5)
log10copies/mL and number of mutations (IAS, October 2005) primary protease inhibitor 4 (0-5),
resistance associated 11 (2-13), NRTI 7 (2-9) and NNRTI 2 (0-6).
Of 11 patients, six had prior exposure to both tipranavir and ENF with three being ENF-naive. At
week 48 minimum decrease in VL was 2.2log10 copies/mL (median -2.7log10) with viral
suppression <50copies/mL for all but two (166 and 465copies/mL). Median CD4 increase was
118cells/mm3. No serious adverse events or grade 3/4 changes in laboratory safety parameters
were reported.
Conclusion: The combination was well tolerated with impressive efficacy over 48 weeks against
three-class resistant HIV. Further studies of this combination are ongoing.
S3-2
Enfuvirtide (Fuzeon) Use in the Texas Department of Criminal Justice
(TDCJ)
David Paar, MD1, Marsha Royder, RN1, Jacques Baillargeon, PhD1
1
Correctional Managed Care, UTMB
Enfuvirtide inhibits the fusion of HIV-1 with CD4 + cells and therefore prevents entry of the virus
into the lymphocyte. It is indicated, in combination with other antiretroviral drugs, for the
treatment of HIV infection in treatment-experienced patients who are failing current therapy.
Enfuvirtide is supplied in glass vials as a powder that must be reconstituted with sterile water and
injected subcutaneously twice per day. In most clinical settings, patients can receive instruction
on self injection and management of injection-related side effects, and can be sent home with a
supply of enfuvirtide in glass vials, needles, and other injecting equipment. In the correctional
setting, these items cannot be distributed for security reasons. In TDCJ 13 patients have been
treated with an enfuvirtide containing regimen. All have received education under the supervision
of a dedicated RN HIV case manager. Patients perform self-injection and receive other
medications in the medical clinic twice daily where injection site reactions can be assessed and
managed. Ten patients have been on treatment long enough to assess response. There was a
mean reduction in viral load of 3.69 logs, and six patients reached undetectable. CD4+ cells
increased by a mean of 119. One treatment regimen was stopped for each of the following
reasons: parole; laboratory abnormality; poor adherence; and patient choice. We believe our
experience with enfuvirtide in the TDCJ can be used as a model for other correctional systems to
incorporate or build upon.
S3-3
Similar Changes in Metabolic Parameters of Darunavir and Atazanavir,
Each Coadministered with Low-Dose Ritonavir in Healthy Volunteers
Frank Tomaka1
1
Tibotec Inc.
Background: This study evaluated the effects of once-daily darunavir (DRV; PREZISTATM)
coadministered with low-dose ritonavir (r; [DRV/r]), which is the dosing being studied in
antiretroviral-naïve adults, and atazanavir/r (ATV/r) on metabolic parameters in HIV-negative
volunteers.
Methods: In Session 1 (Days 1 through 7), all volunteers received ritonavir 100mg daily. In
Session 2 (Days 8 through 28), either DRV/r 800/100mg daily (n=25) or ATV/r 300/100mg daily
(n=24) was added. Lipids, glucose, and insulin were measured under fasting conditions. Shortterm safety and tolerability were also evaluated.
Results: Forty-nine male subjects were enrolled; 45 subjects (DRV/r n=22, ATV/r n=23)
completed the study. Four (8%) subjects discontinued: 2 on DRV/r due to adverse events (AE),
one from each group withdrew consent. After 7 days of ritonavir, triglycerides increased 30mg/dL
and other lipid parameters showed little change. During DRV/r or ATV/r treatment, mean lipid and
glucose levels showed minimal change from day 7, and no grade 3 or 4 lipid or glucose
elevations were reported. Mean insulin levels decreased by ≥1 mU/L for DRV/r and increased
slightly for ATV/r between days 7 and 28. Adding DRV decreased ritonavir exposure by 14%;
adding ATV increased ritonavir exposure by 69%. AEs that occurred in ≥2 volunteers in either
group during Session 2 included diarrhea, urticaria, jaundice and headache.
Conclusions: In HIV-negative volunteers, low-dose ritonavir led to rapid increases in triglycerides.
Addition of DRV or ATV to low-dose ritonavir resulted in small and comparable changes in lipid
and glucose parameters. Both treatments were well-tolerated with few AEs.
S3-4
Tolerability and Preference of Lopinavir/ritonivir (Katetra) Versus Tablets in
an African American Cohort
Rawlings MK1, McGhee TA2, Casey-Bailey S 1, Pasley M3
1
AIDS ARMS Inc, Dallas, TX; 2Absolute Care Medical Center, Atlanta, GA, Abbott Laboratories3
Lopinavir/ritonavir (LPV/r) is a co-formulated protease inhibitor (PI) previously available as softgel capsules (SGC) and oral solution. LPV/r SGC had several limitations including GI tolerability,
food requirement, and the need for refrigeration. A tablet formulation of LPV/r received FDA
approval in 10/2005. This is the first study to compare tolerability and preference of LPV/r tablets
to SGC’s in African American HIV-1 positive subjects.
Methods: This is a phase IV, two-center investigation of LPV/r in twenty-five (25) treatment
experienced African American HIV-1 positive subjects. Subjects with prior SGC experience were
enrolled to compare experience of SGCs to tablet formulation.
Subjects completed
questionnaires addressing physical, social, emotional outcomes, medication satisfaction and
preference pre-switch, at weeks 4 and 12 post switch. Adverse events were also assessed.
Results: The tablet formulation was preferred by 88% of subject citing the following factors: 1)
no need for refrigeration, 2) fewer pills, 3) no food requirement. At week 12 post-switch, the
General Condition Improvement score for tablet was reported to be better for 42% of subjects and
same for 56% of subjects. Modest improvements in General Health and Physical Function were
noted also 4 weeks post-switch. No significant changes were noted in lipids, triglycerides or liver
function or in GI manifestations. Viral suppression (<400 copies/ml) was 76% of patients pre
switch and 70% post switch (p=NS).
Conclusions: In African American subjects, LPV/r tablet demonstrated improved tolerability and a
high degree of preference versus soft-gel capsules. No viral rebound or additional significant
toxicities were noted post switch.
S3-5
Darunavir in Combination with Other Medications: Pharmacokinetic
Interactions
Raymond Pecini1
1
Tibotec Therapeutics
Background: We present data on pharmacokinetic interactions between darunavir (DRV;
PREZISTA™) coadministered with low-dose ritonavir (DRV/r) and other medications commonly
used in HIV-infected patients.
Methods: The effect of DRV/r was studied when coadministered with: atazanavir (ATV), indinavir
(IDV), lopinavir/r (LPV/r), saquinavir/r (SQV/r), efavirenz (EFV), nevirapine (NVP), TMC125,
tenofovir (TDF), atorvastatin (AVS), omeprazole (OME), ranitidine (RAN), sildenafil (SIL),
clarithromycin (CLA), sertraline (SER), paroxetine (PAR), oral contraceptives (OC), ketoconazole
(KTZ), pravastatin (PRA), and digoxin (DIG).
Results: DRV/r increased exposure to EFV (21%), NVP (27%), TDF (22%), IDV (23%), LPV
(9%), KTZ (212%), CLA (57%), AVS (4-fold), SIL (4-fold), PRA (81%), and DIG (77%), and
decreased exposure to TMC125 (30%), SER (49%), PAR (39%), and ethinyl estradiol (44%).
There was no change in ATV or SQV. DRV exposure increased by 21%, 24%, and 42%,
respectively, when combined with TDF, IDV, and KTZ, and decreased by 13%, 13%, 36%, and
40%, respectively, when combined with EFV, CLA, SQV/r, and LPV/r, and was unchanged when
combined with ATV, NVP, TMC125, AVS, OME, RAN, SER, and PAR.
Conclusions: DRV/r can be combined with many agents with no DRV/r dose adjustments. Some
coadministered agents may require dose adjustments (SIL, AVS, KTZ, and IDV). Combining DRV
with LPV/r or SQV/r is not recommended. Additional contraception should be used when OC are
combined with DRV/r. When coadministration of PRA and DRV/r is required, start with the lowest
possible dose of PRA, titrate as necessary, and monitor safety. Drug interactions with DRV/r are
well characterized and manageable.
S3-6
Darunavir Resistance-Associated Mutations: Prevalence in Samples
Received for Routine Clinical Resistance Testing
Alex Rinehart1
1
Tibotec Therapeutics
Background: In the POWER studies, the number of darunavir (DRV; PREZISTA™) resistanceassociated mutations (RAMs) at baseline was predictive of virologic response. We report the
prevalence of DRV RAMs in clinical isolates with evidence of resistance to protease inhibitors
(PI).
Methods: Approximately 208,000 samples were submitted to Virco for routine resistance testing
in 1998–2006. Evidence of resistance to PIs was defined as (1) any change at amino acid
positions 30, 32, 36, 46, 47, 48, 50, 53, 54, 73, 82, 84, 88, or 90, or (2) predicted fold change in
IC50 above the respective vircoTYPE lower clinical cut-off (vircoTYPE v. 4.0.01) for any PI.
Results: 108,500 (52%) samples had evidence of PI resistance according to the mutation list. In
these samples, the DRV RAMs occurring most frequently were I84V (15.1% of samples), G73S
(10.0%), and L33F (9.4%). Others were present in <5%. The majority (68.2%) of isolates with
evidence of PI resistance contained no DRV RAMs; 17.8% harbored one; 8.4% harbored two;
5.6% harbored ≥3. The most frequently occurring combinations of 2 and 3 DRV RAMs were
G73S+I84V (2.2%) and L33F+G73S+I84V (0.3%), respectively. Results were similar for 91,900
samples with evidence of reduced susceptibility to PIs according to vircoTYPE.
Conclusions: More than 2/3 of 108,500 isolates with evidence of PI resistance harbored no DRV
RAMs; 8 of the 11 DRV RAMs occurred in <5% of samples. Co-existence of ≥3 DRV RAMs was
infrequent (5.6%). Results were similar in samples with evidence of reduced susceptibility to PIs
according to vircoTYPE.
S3-7
TMC125 in Treatment-Experienced Patients: An Update
Peter Shalit1
1
Swedish Medical Center
Background: TMC125, a next-generation NNRTI, has potent activity against both wild-type and
NNRTI-resistant HIV-1.
Methods: Available data on TMC125 in treatment-experienced patients and drug–drug interaction
data are reviewed.
Results: In an active control dose-finding study, TMC125 demonstrated significant and durable
efficacy in treatment-experienced patients with NNRTI resistance. At 48 weeks, mean change in
log10 viral load (ITT, NC = F) at the selected dose of TMC125 was –1.01 versus –0.14 for control.
At the same dose, 22% of patients on TMC125 achieved an undetectable viral load (88% of
whom maintained to Week 48) versus 0% of controls. Data on the impact of NNRTI resistanceassociated mutations on TMC125 fold change and outcome are evolving and confirm the in vitro
virologic profile of TMC125. Favorable safety and tolerability for TMC125 have been
demonstrated in a placebo-controlled, double-blind trial. The most common adverse events (AEs)
were diarrhea, abdominal pain, nausea, headache, and rash. Only rash was numerically more
frequent with TMC125 than with placebo and was generally mild to moderate with infrequent
discontinuations. No frequent or consistent neuropsychiatric AEs were reported compared with
placebo. Extensive drug-drug interaction data with TMC125 indicate it can be coadministered
without dose adjustment with most medications commonly used in HIV-infected patients.
Conclusions: TMC125 is the first NNRTI to demonstrate significant and durable efficacy in
treatment-experienced patients with NNRTI resistance, with a favorable safety and tolerability
profile. TMC125 can be combined with most medications without dose adjustment. The DUET
registrational trials are ongoing in treatment-experienced patients.
S3-8
TMC125 in Combination with Medications Commonly Used in HIV Infection:
Summary of Drug-Drug Interactions
Deb Israel1
1
Tibotec Therapeutics
Background: TMC125, a next generation NNRTI with potent activity against wild-type and NNRTIresistant HIV-1, is a substrate and inducer of CYP3A4 and a substrate and inhibitor of CYP2C.
Pharmacokinetic (PK) interactions between TMC125 and other medications commonly used in
HIV-infected patients are summarized.
Methods: Steady-state PK studies were conducted: two-way interaction studies with TMC125 and
rifabutin, clarithromycin, didanosine, tenofovir, atazanavir and ritonavir-boosted (/r) protease
inhibitors atazanavir, darunavir, and tipranavir; one-way effect of omeprazole and ranitidine on
single-dose TMC125; and one-way effect of TMC125 on (fos)amprenavir, boosted lopinavir with
saquinavir, methadone, oral contraceptives (OC) and single-dose sildenafil.
Results: TMC125 had no clinically relevant effect on rifabutin, OC, didanosine, methadone,
tenofovir and the boosted protease inhibitors darunavir, atazanavir, lopinavir with saquinavir or
tipranavir. TMC125 increased exposure to (fos)amprenavir 69%, and decreased exposure to
sildenafil 57%, and clarithromycin 39%. No clinically relevant changes in TMC125 exposure were
observed when combined with rifabutin, clarithromycin, didanosine, tenofovir, darunavir/r,
atazanavir, atazanavir/r and omeprazole or ranitidine. TMC125 exposure decreased 76% with
tipranavir/r. When co-administered with lopinavir/saquinavir/r, (fos)amprenavir, methadone, oral
contraceptives or sildenafil, TMC125 PK were comparable to historical controls.
Conclusions: TMC125 can be combined with many drugs without dosage adjustment. Dose
adjustments may be required for (fos)amprenavir and sildenafil. TMC125 is not recommended in
combination with tipranavir/r. Use of an alternative to clarithromycin is recommended when
treating Mycobacterium avium complex. Interactions of TMC125 with drugs commonly used in
HIV therapy are well-characterized and manageable.
S4-1
The Clinical Utility, Safety and Tolerability of Polylactic Acid Injections
(PLA) for HIV-Related Facial Lipoatrophy at the San Francisco Veterans
Affairs Medical Center
Harry Lampiris, MD1, Cindy Burt, RN2, Heather Sourthwell, AS3, Mai Vu, PharmD4, Thea Mauro,
MD5, Isaac Neuhaus, MD5, Phyllis Tien, MD1
1
Medicine/Infectious Disease Section, San Francisco VA Medical Center, 2Nursing, San
Francisco VA Medical Center, 3Metabolism Section, San Francisco VA Medical Center,
4
Pharmacy, San Francisco VA Medical Center, 5Dermatology, San Francisco VA Medical Center
The development of facial lipoatrophy (LA) in the setting of antiretroviral therapy has been
associated with decreased quality of life (QOL) and adherence to life-prolonging antiretroviral
therapy. Polylactic acid (PLA) injections were recently FDA approved for HIV-associated LA, but
the cost of therapy (on average $4000 per patient for 4 monthly sessions) may be prohibitive in
publicly funded HIV clinics. At the SFVAMC, facial LA was identified as a common complaint of
HIV-infected patients seen in the Infectious Diseases (ID) Clinic. We obtained funding to provide
PLA injections to HIV-infected patients with moderate and severe lipoatrophy. Eligibility for PLA
was established using a standardized clinical assessment of lipoatrophy (0=no lipoatrophy,
1=mild lipoatrophy, 2= moderate lipoatrophy, 3=severe lipoatrophy) by an independent panel of at
least 1 infectious disease physician and 1 registered dietitian experienced in the management of
lipoatrophy. Of 15 number of patients who self-referred from the ID Clinic, 8 patients were
identified as having an average LA score >2 and referred to a dermatologist with expertise in PLA
injections for at least 3 monthly injections. We will describe the outcomes of HIV-infected patients
who received PLA injections using objective measures including changes in facial anthropometry,
QOL and actual facial photos from baseline. The cost of PLA coverage for our clinic has been
surprisingly low because of the identification of relatively few patients with moderate to severe
facial lipoatrophy, possibly because delayed access to this intervention led to patients seeking
treatment in non-VA health care settings.
S4-2
HIVAN and IgA Nephropathy as a Cause of Chronic Kidney Disease
Jennifer Klein, FNP1, Ejeanne Queen, FNP1, Edna Toubes Klingler, MD1, M. Keith Rawlings1
1
Peabody Health Center
HIVAN and IgA Nephropathy as a Cause of Chronic Kidney Disease
Presenters:
Jennifer Klein FNP, Edna Toubes Klingler MD, Ejeanee Queen FNP, M. Keith Rawlings MD
Peabody Health Center/AIDS Arms, Inc.
1906 Peabody Ave.
Dallas, TX 75215
[email protected]
(214)421-7848 phone
(214)421-1119 fax
Introduction:
Though HIV-associated nephropathy (HIVAN) receives a great deal of attention, causes of
chronic kidney disease in HIV-infected patients are varied and multifactorial. We present the
case of a man with renal failure, having features of both HIVAN and IgA nephropathy on renal
biopsy.
Case:
A 30 y/o Hispanic man presented for initial outpatient HIV care. Baseline laboratory results
included: CD4 18 cells/uL, HIV RNA 80,952 copies/mL, hemoglobin 7.9 g/dL, BUN 47 mg/dL,
creatinine 7.0 mg/dL, and CO2 13 mmol/L. Hepatitis B and C serologies, and RPR were negative.
Patient had recent history of celecoxib use.
Patient was hospitalized where evaluation showed unremarkable abdominal CT scan and renal
ultrasound. Renal biopsy revealed global glomerular sclerosis consistent with a diagnosis of both
advanced HIVAN and IgA nephropathy. Following one month of antiretroviral therapy with
atazanavir boosted with ritonavir, renal-dose lamivudine, and didanosine, the patient experienced
improvement in renal function (BUN 34 mg/dL, creatinine 2.5 mg/dL). His HIV RNA declined to
436 copies/mL and CD4 remained steady at 17 cells/uL.
Discussion:
Renal disease may be multifactorial, especially as drug-toxicities and manifestations of other
chronic illnesses play larger roles. IgA nephropathy is a noted cause of kidney disease in HIV
patients, thought secondary to IgA directed against HIV antigens. The diagnosis of HIVAN ideally
should be made by biopsy and not as a default diagnosis. Other etiologies must also be
considered as is demonstrated by our case.
Reference:
Gupta, Samir et al. Guidelines for the Management of Chronic Kidney Disease in HIV-Infected
Patients: Recommendations of the HIV Medicine Association of the Infectious Diseases Society of
America. Clinical Infectious Diseases, 2005;40:1559-1585.
S4-3
Non-Hodgkin’s Lymphoma (NHL) of the Pituitary Initially Presenting with
Panhypopituitarism and Report of a Single Institution Experience with
Primary CNS Lymphoma (PCNSL) Between 1998-2007
Kelly A. Shimabukuro, MD1
1
UCSD Medical Center
We report the first case of NHL of the pituitary in an HIV-positive patient. We find only one other
case reported of pituitary NHL occurring in an HIV-negative patient. The patient (CD4 369, ARVnaïve, no prior opportunistic infections) presented with nausea, vomiting, and electrolyte
abnormalities. Examination revealed intact neurological and visual function. Laboratory
examination revealed hypernatremia, transaminitis, undetectable serum cortisol, and
panhypopituitarism. Imaging showed pituitary mass. PET scan demonstrated increased uptake
in pituitary, left axilla and RUL, concerning for CNS involvement of systemic lymphoma. Tissue
biopsy of pituitary lesion confirmed NHL. He received steroids post-brain biopsy with resolution
of axillary lesion prior to biopsy attempt to confirm PCNSL vs systemic NHL. He was started on
kaletra/truvada and systemic chemotherapy with high-dose methotrexate. Course has been
complicated by neutropenic fever in setting of severe disseminated CMV disease with retinitis,
encephalitis, and colitis. Because of concerns for infection, pt has not received further
chemotherapy. Follow-up brain MRI shows no lesion and CT chest/abd/pelvis are negative. We
believe his prognosis to be good with antiretroviral therapy and are discussing plans for future
chemotherapy.
At our institution, a total of 14 cases of confirmed primary CNS lymphoma were seen between
1998 - 2007. Mean CD4 43.6 (range 1-133) with mortality rate of 86% and median time of
survival 144 days (95% CI 47-894). Few cases were confirmed by brain biopsy, most diagnosed
based on imaging and CSF analysis. This series and our case report illustrate the difficulty in
making the diagnosis of a primary brain lesion.
S4-4
Increasing Incidence of Colorectal Cancer in the HIV Atlanta VA Cohort
Study (HAVACS)
Jodie Guest, PhD1, Abeer Moanna, MD1, David Rimland, MD1
1
Atlanta VA Medical Center and Emory University School of Medicine
Background: There have been several reports of non-AIDS defining malignancies, including
colorectal cancer, that are emerging as significant problems.
Methods: We reviewed all diagnoses of colon, rectal and anal cancer in the HIV Atlanta VA
Cohort Study (HAVACS), a prospective study of 2999 patients followed since 1982.
7
1000
6
5
800
4
600
3
400
2
2006
2004
2002
2000
1998
1996
0
1994
0
1992
1
1990
200
Cases of CRC
1200
1988
Patients in HAVACS
Results: 32 patients were diagnosed with colorectal cancer (CRC) since 1988; 25 after 1999. The
incidence since 2000 is 3.8 cases per 1000 vs. 1.5 per 1000 before 2000 (p=0.028); this rate is 3
times that in the general US population. Standard screening is low despite a rapidly growing older
population. However, 53% of those diagnosed were less than 50 years at the time of diagnosis,
the recommended screening age, and 2 were less than 40. African Americans (AA) accounted
for 70% of the cases. Of interest, the racial distribution was significantly different based on CRC
location; 53% of those diagnosed with anal-rectal cancer were AA compared to 87% diagnosed
with colon cancer (p=0.046). Two cases of CRC were diagnosed prior to HIV diagnosis. For
those with a preceding HIV diagnosis, the average time of CRC was 10 years after HIV diagnosis.
Greater than half have died since CRC diagnosis with a median time to death of 15 months.
Conclusions: The incidence of CRC in this HIV+ cohort is increasing and the age distribution is
much younger than non-HIV cohorts. Possibly, the recommended screening age is too high for
HIV+ patients. Colorectal cancer should be added to the malignancies now being seen in HIV+
patients.
S4-5
Long-term Hepatic Safety of Protease Inhibitors Including
Lopinavir/Ritonavir Containing Regimens in the Treatment of HIV-HBV CoInfected Patients
Homayoon Khanlou, MD1, Ashwaq Hermes, PharmD2, Richard Rode, PhD2, Rick Stryker, MD2,
Charles Farthing, MD1
1
Medicine, AIDS Healthcare Foundation, 2Abbott Laboratories
Background: Hepatitis-B virus is a major source of morbidity outside of United States. There is
limited data regarding the liver toxicity of antiretroviral therapy in HIV-HBV co-infected patients.
Methods: Our objective was to compare the incidence of hepatotoxicity, defined as ALT/AST >5 x
upper-limit of normal (if ALT/AST normal at baseline) or 3.6 x baseline (if ALT/AST elevated at
baseline), between different HAART combinations and boosted HIV-protease inhibitors (PI/r),
including lopinavir/ritonavir (LPV/r). We retrospectively assessed all HIV-HBV co-infected patients
at our institution followed for 1 year.
Results: We identified 107 HIV-HBV co-infected patients, of which 6 were excluded from analysis
(concomitant PI+NNRTI therapy). Treatment arms were: No ART=control (n=10); NRTIs alone
(n=5); NNRTI (n=21); LPV/r (n=19); and other PI+RTV (n=46). Median (range) age was 42 (2468) years, with 93% male and 41% Caucasian, 36% African-American, and 16% Hispanic.
Median (Baseline / Change) HIV-VL (log10 copies/mL) and CD4+ T-cell count (cells/mm3) were
respectively 3.7 / + 0.3 and 670.5 / – 117.5 for the control arm, 2.1 / + 0.4 and 620 / – 43 for the
NRTI arm, 2.7 / -0.4 and 286.0 / + 60 for the NNRTI arm, 4.4 / -1.3 and 212.5 / + 71 for the other
PI/r arm, and 4 / – 0.9 and 189 / + 95 in the LPV/r arm. Incidence of ALT & AST elevation per
treatment arm are reported in table below:
No ART (Controls)
NRTIs NNRTI
LPV/r Other PIs/r
ALT elevation (IU/L)
0/10
0/5*
1/21**
0/19*
0/46*
AST elevation (IU/L)
0/10
0/5*
0/21*
0/19*
0/46*
ALT/AST elevation (IU/L)
0/10
0/5*
1/21**
0/19*
0/46*
Fisher’s exact p-values for comparison with No ART (Controls): * p>0.999; ** p=0.677
Conclusions: All HAART combinations appeared equally safe in HIV-HBV co-infected patients.
Clinicians should not be reluctant to use boosted HIV-protease inhibitor containing regimens in
HIV-HBV co-infected patients.
S4-6
Seronegative Acute Hepatitis C Mimicking HAART-Induced Hepatotoxicity
Olga Ali, MS1, Kimberly Summers, PhD1, Gregory Anstead, MD1
1
Infectious Disease, South Texas Veterans Health Care System
Background: During early HCV infection, there may be a window period in which no anti-HCV
ntibodies are present. Just as in early HIV infection, the key to making the diagnosis of acute
hepatitis C in this window period is to obtain a viral load, as this case demonstrates.
Case: A 63 y/o HM with AIDS (CD4 =163(13%); HIV viral load (VL) 671) presented with nausea,
jaundice, scleral icterus, and AST and ALT levels 10x ULN. Medications included abacavir,
boosted atazanavir, emtricitabine/tenofovir, trimethoprim/sulfamethoxazole, atenolol, gemfibrozil,
and hydrochlorothiazide. Serologic testing revealed: HAV IgG+, HBV sAg- / sAb+/ cAb+, HCV
Ab-. The initial impression was HAART-induced hepatitis and all medications were stopped.
Nevertheless, the AST and ALT increased to 20-X ULN. Subsequently, HCV VL was determined
to be >43 million. Thus, the patient had seronegative acute hepatitis C. Computerized
tomography showed a cirrhotic liver (from a prior hepatic insult). AST and ALT levels peaked at
1896/990 and then declined to normal over 2 weeks. The patient was re-initiated on HAART and
early hepatitsis C therapy is planned.
Conclusions: This case demonstrates that determination of the hepatitis C VL may be necessary
to make the diagnosis of acute hepatitis C because of the serologic window period.
Seronegativity during acute hepatitis C may be more common in HIV infection because of
decreased humoral immune response. Recognition of acute hepatitic C is important because
prompt treatment after acute disease optimizes the response to therapy.
S4-7
Concurrent Infection with Mycobacterium Avium-intracellulare,
Pneumocystis Jiroveci and Cytomegalovirus: An Unusual Manifestation of
HIV Immune Reconstitution Inflammatory Syndrome
Oksana Anand, MD1, Arundhati Desai, MD2, Vinutha Kumar, MD2
1
Department of Medicine, Kansas City VAMC and KUMC, 2Infectious Diseases, Dept. of
Medicine, Kansas City VAMC
Highly active antiretroviral therapy (HAART) can improve immunocompetence in HIV patients,
even when the immunodeficiency is advanced. This has decreased the morbidity and mortality
associated with HIV infection. Approximately one-quarter of patients who start HAART
experience an Immune Reconstitution Inflammatory Syndrome (IRIS) event. Patients with
advanced immunodeficiency at HAART initiation are at greatest risk of developing IRIS
sometimes resulting in death. This will be common as the HAART-era continues.
We report an unusual case of a 54- year old male with longstanding AIDS and concurrent
infection with three opportunistic pathogens, namely Mycobacterium avium intracellulare,
Pneumocystis jiroveci and CMV. The syndrome developed within three weeks of restarting
HAART. Despite improvement in HIV viral load and treatment with targeted anti-infective therapy,
he developed worsening clinical, laboratory, and radiological findings and succumbed to his
illness. This could only be explained by HAART-induced robust immune response, leading to
augmentation of inflammatory response to opportunistic pathogens.
Our review of literature identified no previously reported cases of IRIS in HIV patients
presenting with three concurrent opportunistic pathogens. Limited data regarding
standard for diagnosis and treatment of IRIS, as well as its unusual presentation makes it
a modern day challenge. It is interesting to debate as to how to predict which patient
would develop IRIS and when the risks of starting HAART would outweigh the benefits in
advanced disease.
S4-8
“Clinical Indications and Diagnosis of Lymphogranuloma Venereum (LGV)
in HIV Positive Men Who Have Sex With Men (MSM) at Whitman-Walker
Clinic”
Akbar Shahkolahi, PhD1, Philippe Chiliade, MD2
1
Whitman-Walker Clinic, 2Family Health International
Lymphogranuloma venereum (LGV) is a systemic and invasive STI caused by Chlamydia
trachomatis (CT) serovars L1, L2, and L3. CDC recommends routine screening for Chlamydia
infection among at-risk MSM in order to prevent disease complications and to reduce the risk of
HIV transmission.
In the course of validating a BD ProbeTec TM ET Chlamydia trachomatis amplification DNA
assay (NAATS) using rectal specimen, convenient samples were collected from 50 men who had
recent receptive anal intercourse attending a STD/HIV program.
Among 50 individuals screened, 28 (56%) were HIV positive, 26 (51%) showed rectal symptoms
and 24 (49%) were asymptomatic. Symptoms included pain, inflammation, abscess, perianal
sore, ulceration, proctitis and a mucopurulent rectal discharge. Ten individuals (20%) were
positive for CT in the initial screening using NAATS assay. Three were asymptomatic of whom
two were HIV negative. The remaining seven individuals presenting anorectal symptoms were
HIV positive. All positive CT samples were submitted to CDC for LGV identification. Three
specimens (30%) were identified as LGV by sequencing a chlamydia-specific gene (ompA) and
seven were non-LGV. No single clinical symptoms were specific of LGV infection. In our sample
all three LGV cases were symptomatic, however 4 of 7 (57%) of non-LGV cases were also
symptomatic.
Routine CT testing followed by molecular identification of LGV is recommended. Clinical
presentation alone seems unreliable for diagnosis of LGV. Convenient sampling was a limitation
of this study. A prospective assessment of the prevalence of CT including LGV among MSM
reporting anal receptive sex is presently being conducted.
S4-9
Report of a Solitary Renal Aspergilloma in an AIDS Patient: Nearly Two
Year Survival after Successful Treatment with Nephrectomy
Joe Caperna, MD1
1
UCSD
GU aspergillus is rare but has a high risk of death without surgical debridement. We report here
successful treatment of a case of renal aspergilloma in an AIDS patient with nephrectomy and
multi-antifungal therapy(MAT). We know of only three other cases in AIDS patients reported in
the medical literature. Other involvement in this patient only included an aspergillus prostatic
abscess; we found 6 other cases reported.
MM was a 33 year old gentleman with pan-resistant HIV, cd4<10, who presented in November
2003 with fevers, dysuria for almost 2 weeks with persistent pyuria despite 5 days of antibiotics.
Imaging showed a large retroperitoneal abscess. CT-guided biopsy showed fungal elements.
MAT with itraconazole, amphotericin and caspofungin(IAC) led to worsening abscess.
Nephrectomy was difficult; intraoperative photographs are impressive. Salvage ARV therapy with
enfuvirtide led to HIV PCR<400 within 4 weeks. Voriconazole was tried but resulted in
undetectable levels because of ritonavir interaction. After 6 months of MAT, amphotericin and
caspofungin were stopped and the abscess recurred within one month. IAC was restated, and
along with drainage, led to resolution of the retroperitoneal abscess. Three months later,
amphotericin was stopped but itraconazole and caspofungin were continued. Re-imaging
showed the abscess recurred a second time. The patient died 23 months after nephrectomy from
prolonged neutropenia and difficult to treat CMV encephalitis. CD4 count never rose above 20,
despite repeated HIV PCR’s <400. This case represents successful treatment of renal
aspergilloma with nephrectomy and MAT. Imaging throughout his course dramatically documents
resolution and recurrence of the abscess.
S4-10
Renal Function in Tenofovir–Exposed and –Unexposed Patients Receiving
HAART in the HIV Outpatient Study (HOPS) Cohort
John T. Brooks, MD1
1
Centers for Disease Control and Prevention, Atlanta, GA
Background: Cases of renal dysfunction have been reported in HIV-infected patients taking
tenofovir (TDF), but few large studies have examined population-level changes in renal function
in patients in routine care.
Methods: Antiretroviral-naive and -experienced patients in the HOPS cohort who received >1
month of HAART with or without TDF after November 1, 2001 were analyzed. Patients with
baseline creatinine >1.5 mg/dL or creatinine clearance (CrCl) <50 mL/min, renal disease, or
cidofovir or adefovir exposure were excluded.
Results: The 593 TDF-exposed and 521 TDF-unexposed patients analyzed had a median followup of 1.6 years and generally similar baseline risks for renal disease; the TDF-exposed included
more men (86% vs 78%), more whites (73% vs 63%), and fewer antiretroviral-naive patients
(13% vs 22%) (all P≤ 0.01). Median baseline CrCl (by Cockcroft-Gault equation) was 106 mL/min
for TDF-exposed and 110 mL/min for TDF-unexposed patients (P=0.06). In multivariable
analyses, 1-year changes in CrCl were -5.7 mL/min among TDF-exposed and 2.6 mL/min among
TDF-unexposed patients, and changes in glomerular filtration rate (GFR) by MDRD equation
were -6.1 mL/min/1.73m2 and 0.8 mL/min/1.73m2, respectively (for both, P<0.001 for difference
by TDF-exposure group). Seven TDF-exposed and 3 TDF-unexposed patients had incident
diagnoses of renal disease (incidence rates of 0.7 and 0.4 per 100 person-years, respectively,
P=0.49); among TDF-exposed these diagnoses could be attributed to other risk factors.
Conclusions: In this large diverse cohort of HIV-infected U.S. patients, use of TDF-HAART was
associated with average 1-year decreases in CrCl and GFR of 5%-7%. Clinically significant
incident renal toxicity was infrequent.
S5-1
"Methamphetamine Abuse and Neurosyphilis in a HIV Positive Male" A
Case Report.
Richard Solero, MD1, Kevin Sherin, MD2, Steven Hale, MD3
1
Immunology, Orange County Health Department, 2Orange County Health Department, 3Orange
Conty Health Department
Richard Solero, MD*; Kevin Sherin, MD, MPH; Steven Hale, MD, MPH
Orange County Health Department
832 W. Central Blvd
Orlando, FL 32805
(407)-836-2683 office
(407)-836-2543 fax
Abstract: Comprehensive care
Case Report:
A 33 year old white MSM male, known HIV positive since 2001, presented to the immunology
clinic for his initial medical evaluation. His chief complaint was recurrent headaches with
photophobia of several weeks duration, attributed to sinuses. He reported a 20 pound weight loss
and fatigue. A substance abuse history demonstrated occasional alcohol consumption and crystal
methamphetamine addiction of 1 year duration. Sexual history is positive for multiple high risk
unprotected sexual encounters, exacerbated by the influence of crystal methamphetamine abuse.
He self-stopped antiretroviral medications. The physical examination was unremarkable.
Laboratory results RPR was positive at 1:512 dilutions with a positive confirmatory FTA. A
previous RPR done in 2002 was reported negative. A brain CT was negative. Lumbar puncture
yielded an elevated protein, normal glucose level, pleocytosis, and a positive CSF VDRL. The
diagnosis of neurosyphilis was confirmed. The patient was successfully treated with 14 days of
intravenous penicillin. The latest follow up RPR is 1:4 dilutions; the patient remained symptom
free and is demonstrating an excellent response to therapy.
Methamphetamine abuse is a major public health problem in the US and worldwide. Our case
presents an HIV positive MSM that developed neurosyphilis infection after 12 months of crystal
methamphetamine abuse due to multiple high risks unprotected sexual contacts while under the
influence of the drug. Methamphetamine abuse is a critical public health problem that adversely
affects our communities increasing the risk of HIV and other STD’s acquisition.
Methamphetamine abuse requires an integrated service delivery approach.
S5-2
Physical Activity and HIV: Who Does, How Much?
Soula Fillipas1, Christine Bowtell-Harris, RN1, Flavia Cicuttini, MBBS2, Anne Holland, PhD3,
Catherine Cherry, MBBS4
1
The Alfred, 2Monash University, 3La Trobe University, 4The Burnet
Physical activity and HIV: Who does how much?
Presenter
Soula Fillipas
B.Physio, MPH, PhD Candidate
The Alfred
PO Box 315 Prahran Victoria 3181 Australia
Tel: +61 (3) 9276 3450
Fax: +61 (3) 9276 2702
Email: [email protected]
Physical activity confers health benefits for people living with the human immunodeficiency virus
(HIV), however little is known about the prevalence of physical activity. This study was designed
to describe physical activity in an Infectious Diseases (ID)/ HIV clinic, assess compliance with the
Centres for Disease Control and Prevention and American College of Sports Medicine physical
activity guidelines, examine whether patients attending for ongoing HIV care had different
physical activity levels from those with other infections and assess demographic associations.
All patients attending the Alfred ID clinic over four weeks were invited to complete the
International Physical Activity Questionnaire Short Form (IPAQ). Self- reported data on gender,
age and HIV- status were also collected.
Three hundred and forty seven patients attended during the study period, and 261 (75.2%)
participated. This included 191 HIV positive patients (87% response rate) and 70 HIV negative
patients (55% response rate). Mean age (43.3years) and range (18-81 years) were similar in both
groups. HIV positive patients were more likely to be male (p<0.001).
Most respondents were either moderately or highly active. Overall, 73.8% of HIV positive and
65.7% of HIV negative respondents met recommended guidelines. There were no differences
between the proportion of respondents classified into the IPAQ categories or meeting the
guidelines according to HIV status, age or gender.
This cross sectional study found that 28.0% of patients were inactive, including 25.7% of patients
attending for management of chronic HIV infection. Inactivity could not be predicted on the basis
of simple demographics.
S5-3
The Effects of a Supervised Exercise Program on Self Efficacy in HIV/AIDS
Soula Fillipas, MPH1, Leonie Oldmeadow, PhD1, Michael Bailey, PhD2, Catherine Cherry, MBBS3
1
The Alfred, 2Monash University, 3The Burnet
The effects of a supervised exercise program on self efficacy in HIV/AIDS.
Presenter
Soula Fillipas
B.Physio, MPH, PhD Candidate
The Alfred
PO Box 315 Prahran Victoria 3181 Australia
Tel: +61 (3) 9276 3450
Fax: +61 (3) 9276 2702
Email: [email protected]
The aim of this study was to evaluate the effects of a six month supervised exercise program for
people living with HIV/AIDS on self efficacy, quality of life status and cardiovascular fitness. The
design was a single blinded randomized controlled trial. Subjects were 40 male HIV-infected
individuals randomly allocated to either an experimental (n=20) or a control (n=20) group. The
experimental group participated in a twice weekly supervised aerobic and progressive resisted
exercise programme. The control group participated in a twice weekly individual walking program
and attended a monthly group forum. Outcome measures were a Generic Self Efficacy Scale; a
one minute heart rate response post three minute step test, and the MOS-HIV Health Survey.
Measurements were taken at baseline, two months and six months. The experimental group
improved significantly in self efficacy [mean increase 5.3 points (p<0.0001)] and in cardiovascular
fitness [mean decrease 17 points (p<0.0001)].The experimental group also improved in eight out
of the 11 dimensions of quality of life at six months (p<0.05), while the control group did not.
These results demonstrate that a six month supervised exercise program improves self-efficacy,
cardiovascular fitness and quality of life in people living with HIV/AIDS.
S5-4
Comprehensive Care Clinic Visits Are Associated with Better Control of HIV
Tuyen Hoang, PhD1, Matthew Goetz, MD1, Elizabeth Yano, PhD1, Barbara Rossman, PhD1,
Henry Anaya, PhD1, Herschel Knapp, PhD1, Allen Gifford, MD2, Steven Asch, MD1
1
HSR&D, VA GLA HEALTHCARE SYSTEM, 2VA BEDFORD HEALTHCARE SYSTEM
Background: Control of viral replication through HAART improves HIV patient outcomes. Yet
many HIV patients have significant co-morbidities that pose significant social and clinical
challenges to achieving viral suppression. Integrating subspecialty services into comprehensive
HIV primary care clinics has been hypothesized to address such challenges, but no study has
evaluated their impact on treatment outcomes.
Methods: We conducted a retrospective cohort study using data from a Veterans Affairs regional
electronic database from 2000-2006 to identify HIV patients from five sites in the Western US. We
interviewed the chiefs of the HIV clinics to rank the degree of comprehensiveness of their clinics
on a 1-4 scale. These rankings were applied to patient visits to form an index of comprehensive
care utilization for each patient. Using survival analysis, we estimated the association of
comprehensive care utilization and time from first receipt of HAART to first achievement of viral
load 400 copies/mL or less (VL400-).
Results: 759 HIV positive patients were eligible for the analysis. Utilization of comprehensive HIV
care was significantly positively associated with time to VL400- (hazard ratio HR=1.04, p=.04)
even when adjusting for clinical and socio-demographic factors. Other significant clinical
predictors included frequency of HAART refills (HR=1.71, p=.001), baseline viral load (HR=0.92,
p=.003), first receipt of HIV treatment after versus before October 2000 (HR=1.67, p<.001).
Conclusions: Patients who utilized comprehensive care clinics more regularly were more likely to
achieve VL400-, independent of socio-demographic characteristics, access to medication and
disease severity. This finding supports channeling HIV patients to comprehensive care clinics.
S5-5
Training Strategies Targeting Oral Health Care Providers - An Effort to
Encourage Comprehensive Care
Jacqueline Plemons, DDS1, K. Vendrell Rankin, DDS1, Elain Benton, BS1
1
Public Health Sciences, Baylor College of Dentistry LPS, TX/OK AETC
Baylor College of Dentistry, Texas A&M Health Science Center is a Local Performance Site for
the Texas/Oklahoma AIDS Education and Training Center. In an attempt to improve access to
comprehensive care for HIV/AIDS patients, Baylor has initiated a series of educational efforts
aimed at dental health care providers. Training ranges from small to large group interactive
lectures including case studies and group discussion. Clinical preceptorships are offered several
times a year allowing for hands-on evaluation of HIV/AIDS patients in a clinical setting. Clinical
consultations are available on a continuing basis providing quick and up-to-date information
regarding specific aspects of HIV/AIDS dental care. Training topics include dental management
of HIV/AIDS patients, oral manifestations of HIV infection, blood-borne pathogen training,
AIDS/HIV epidemiology and pathogenesis, as well as post-exposure prophylaxis. In an attempt
to reach a large audience of dental health care providers, an HIV/AIDS-related Case Report and
Self-Study is published each year in the Texas Dental Journal. The Case Report is followed by
approximately ten questions for which continuing education credit can be earned by answering
and submitting the appropriate documentation. The article along with the Self-Study is reprinted
in the Oral Disease Update that is distributed annually to 6800 licensed and registered dental
hygienists across the state of Texas. Last year approximately 180 dental health care providers
completed the Self-Study and submitted the required documentation to receive continuing
education credit. As a result, the effort appears to be effective in disseminating information
regarding the care of HIV/AIDS patients to oral health care providers enhancing the potential for
the provision of comprehensive care.
S5-6
Improving Mental Health Screening Among HIV-Positive Patients
Shaheda Iftikhar, MD1, Sarah Schillie, MD1
1
Division of Patient Care Services, Suffolk County Department of Health Services
In an effort to improve mental health screening among HIV-positive patients, the Suffolk County
Department of Health Services Division of Patient Care Services developed a 2-page mental
health screening tool in 2004. The tool is completed annually for all HIV-positive patients during
the comprehensive examination. It can be completed by the patient (or healthcare professional)
and is reviewed/signed by a licensed healthcare professional. It is maintained as a part of the
medical record. The tool includes screening for depression, anxiety, psychiatric history and
medications, psychosocial assessment, sleep assessment, and appetite assessment.
Audits conducted by an external quality improvement organization (Island Peer Review
Organization, or IPRO) demonstrated improvement in mental health screening rates after
implementation of the screening tool. The results are depicted in Table 1. It is noteworthy that
the all-or-none indicator (#8) demonstrated the most dramatic improvement.
Table 1: Improvement in mental health screening results after implementation of
health screening tool.
Pre
n=130 charts
2003
1. Cognitive Function
90%
2. Depression Screening
86%
3. Anxiety Screening
75%
4. Baseline Psychiatric History
53%
5. Psychosocial Assessment
92%
6. Sleeping Habits Assessment
79%
7. Appetite Assessment
81%
8. Mental Health Assessment (all elements)
42%
mental
Post
n=133 charts
2004
99%
99%
97%
87%
100%
97%
96%
83%
The results demonstrate that a standardized, systematic approach to mental health screening
through utilization of a screening tool is associated with improved mental health screening rates.
Similar tools may be developed for other aspects of care where an identified need for
improvement exists.
S5-7
Prevention with Positives
Shaheda Iftikhar, MD1, Sarah Schillie, MD1
1
Division of Patient Care Services, Suffolk County Department of Health Services
Suffolk County Department of Health Services, Division of Patient Care Services, provides
primary care for HIV-positive patients throughout its network of 8 community health centers. In
an effort to address prevention among HIV-positive patients, a "Prevention with Positives" project
was implemented in 2005. A "Risk Assessment Stamp" was developed for use in the medical
record. The stamp contained questions regarding risk behaviors and facilitated a risk discussion
with the patient. A "Prevention Prescription" was developed that incorporated behavior changes
aimed at reducing transmission. The "Prevention Prescription" was individualized to the patient's
risk behaviors.
Figure 1: Outcome Evaluation
Number of Patients
Outcome Evaluation
40
30
20
10
0
Pre
Post
Last time of sex
unprotected
Last time of IVDU
shared
needles/works
The project was evaluated quantitatively and qualitatively. There were 342 patients seen for a
primary care HIV visit between May 26 and Oct 25, 2005. Of these, 336 charts were included in
the audit (6 records were unavailable for review). An outcome evaluation demonstrated a
decrease in patient-reported risk behaviors (See Figure 1).
Health center staff felt the greatest barriers to compliance with the project included a lack of time
and the sensitive nature of the discussion. However, HIV Consumer Advisory Board members
(who are active health center patients) felt discussion about risk identification and individualized
counseling is very effective in motivating patient behavior change.
S5-8
Rising Above Setbacks to Treatment Access, Care Services for PLWHAs in
a Hard-to-Reach Resource-Poor Community in Snake Island Lagos Nigeria.
Chika Obioma, BS1, Folashade Medahunsi, ACRN2, Anayo Obioma, BA1
1
Programs, Stay Alive Organisation, 2Counseling, Stay Alive Organisation
Introduction:
The Federal Government of Nigeria approved free Antiretroviral Treatment (ART) for PLWHAs in
the country in January 2006.
This unprecedented stride was perhaps the greatest show of political will with regard to
pragmatically addressing one of the most crucial challenges of HIV & AIDS. Events in Nigeria
however indicate that attention to accessibility and other Care services, especially for persons
who live in rural areas and hard-to-reach communities, were not put into consideration.
Issues:
PLWHAs in our community found it extremely difficult to access the free ART for these reasons:
Lack of transport fares to ART centres located in city areas
Lack of money for treatment of opportunistic infections such as tuberculosis and malaria
Stigma at home promotes neglect of PLWHAs
Lack of money to afford food
Non functional clinic for the treatment of common infections
Lack of good water
Stay Alive Organisation partnered with the National HIV and AIDS Project through World Bank
assisted grant to implement a 12 month project on improving access to Counseling/Testing and
provision of care for PLWHAs in Igblogun Community, Snake Island Lagos Nigeria.
Lessons learned:
Access to treatment is more effective if made comprehensive by ensuring that affordability of
services especially at the rural setting are integrated into the scheme.
Strengthening existing structures at the community level leads to impactful and sustainable
response to treatment and care of PLWHAs in hard-to-reach communities.
S5-9
Integrated HIV and Substance Abuse Care among Dually Diagnosed
PLWHAs
Gabriel Griffin1, Rae Jean Proescholdbell1, Frank Lombard1, Nathan Thielman2, Douglas
Thomas1, Janet Scovil3, Katie Cooper4, Barbara Fisher1, Brian Flores1
1
Center for Health Policy, Health Inequalities Program, Duke University, 2Division of Infectious
Diseases and International Health, Department of Medicine, Duke University Medical Center,
3
Duke Addictions Program, Department of Psychiatry and Behavioral Sciences, Duke University
Medical Center, 4Division of Infectious Diseases, Department of Medicine, University of North
Carolina at Chapel Hill
Background: Addressing substance abuse (SA) is critical for the treatment of people living with
HIV/AIDS and highlights the need for integrated behavioral health and medical services.
Integrated care implies a continuum of service models, including coordinated, co-located, and
fully integrated care. This paper describes the implementation of integrated HIV/SA care among a
cohort of dually diagnosed (HIV/SA) PLWHAs in North Carolina.
Methods: Four HIV clinics (2 universities and 2 communities) agreed to integrate SA and HIV
services by co-locating behavioral health providers (BHPs) and adopting site-appropriate
integrated treatment strategies. Clinic patients were screened for a history of SA and offered
enrollment in integrated treatment, involving 12 months of individual and group therapy.
Qualitative interviews about the integration process were conducted with key providers at each
site.
Results: Co-location of BHPs was implemented at all sites and resulted in the engagement of 270
PLWHAs in integrated care. Although all sites agreed that co-location eased communication
(formal and informal) between BHPs and medical providers, sites had varied success adopting
additional integrated treatment strategies. Sites identified the following elements as central to the
further integration of care: universal screening protocol, shared medical records access, and joint
medical and behavioral health treatment planning.
Discussion: Although co-location was an effective means of engaging PLWHAs in SA care, it did
not guarantee seamless integration of HIV and SA services. Fully integrated HIV/SA care
requires intentional, site-appropriate integration efforts to best incorporate co-located BHPs into
the medical clinic setting.
S5-10
End-of-Life Care Discussions: Are They Relevant Anymore?
Katie Mosack, PhD1
1
University of Wisconsin-Milwaukee
Objectives: The purpose of this study was to examine the manner in which HIV providers discuss
death and palliative care with patients.
Methods: Participants were recruited from a university-affiliated infectious disease clinic and a
private, non-profit medical clinic for HIV-positive people in a mid-sized Midwestern city. Between
5/2005 and 6/2006, 11 providers participated in individual semi-structured qualitative interviews.
Topics included initial treatment planning considerations, the involvement of significant or
supportive others in treatment planning, and end-of-life care. Only data pertaining to end-of-life
care were analyzed for this study. Data were coded according to a multilevel coding schema and
analyzed using NVIVO7 software.
Results: With few exceptions, end-of-life care is not usually discussed until treatment options are
nearly exhausted and the patient has been hospitalized. Participants discussed patient and
provider ambivalence including concerns about how the discussion might impair the providerpatient relationship and how it might currently be less relevant in a context of expanded treatment
options. Providers described negative experiences such as when patients or family members
questioned whether the provider was prematurely “giving up” on their treatment. On the other
hand, educating patients about palliative care and the disadvantages of inappropriately
aggressive medical interventions resulted in more positive discussions about the end of life.
Conclusions: Provider ambivalence and perceptions of patient barriers, including denial of the
seriousness of the illness or misperceptions about palliative care can contribute to the avoidance
of end-of-life care discussions. Implications and recommendations for patient care will be
discussed.
S5-11
Incorporating Client Focus Groups in Improving HIV Care
Hela Issaq, MPH1
1
HIV ACCESS/ Family Care Network
Learning Objectives:
1. Develop a cost-efficient, educational and culturally sensitive consumer focus group/workshop
2. Identify information regarding the quality of the medical HIV services provided at a clinic that
can shape quality improvement action plans
3. Articulate to patients how to better advocate for their own health services
Issues:
Treatment advances have made HIV a chronic, manageable disease, but only when there is
close adherence to visits and medications. For these reasons identifying key barriers to care
through consumer feedback has become critical.
Description:
HIV ACCESS, a Title III program, is an HIV health care system made up of diverse sites located
throughout Alameda County in California. We have faced challenges despite significant program
investment, in obtaining continuous consumer improvement feedback. To overcome this
challenge we developed an innovative rotating client focus group moving between sites and using
a standardized format. Our poster will include how we modified published patient empowerment
curricula to allow for a two way conversation about quality of care that both informed patients and
gave the program useable change feedback. These same curricula was further modified and
used with the consumers on the consumer task force of the Family Care Network, the Title IV
program in Alameda County.
Examples of client feedback, action plans and outcome data in terms of patient satisfaction and
number of program changes made based on the patient feedback will be highlighted as well.
S5-12
Outcome in Real Practice with Comprehensive Care in a VA in 2006
Sandra Paez1
1
VA New Jersey
VA New Jersey manages HIV patients in the VISTA/CPRS electronic medical records system
environment. This permits a retrospective assessment of the impact of PIs/NNRTIs on 500
patients under care with respect to HIV control and lipid profiles in a real practice. Of the 500
patients 375 were prescribed NNRTIs/PIs (almost all as boosted, except for NFV), 20 were longterm nonprogressors, 105 patients either refused therapy or did not need therapy yet. Of the 375
treated, 86 were on ATV, 2 DRV, 116 EFV, 23 FPV, 77 LPV, 56 NFV, 13 NVP, and 2 TPV. Blood
lipid levels were compared among the groups. Patients who did not require lipid lowering agents
(LLAs) had similar lipid levels of cholesterol; LDL were: 90, not-done, 93, 101, 98, 122, 103, notdone, respectively; triglycerides were 172, 103, 171, 171, 187, 165, 105, 144, respectively.
Despite LLAs, pts who required them still had much higher levels of chol, LDL, and triglyceride
than those not needing them. Except for patients on DRV and TPV, plasma RNA medians were
all <150 copies/ml, respectively, they were 60, 41K, 54, 132, 144, 56, 49, and 46K. Unlike
prospective clinical trials, in real practice, antiretroviral therapies and LLAs were used and
changed to maximize benefit and minimize harm as needed. The outcome is surprisingly good
for our population with respect to viral suppression (median of 63 c/ml) and to lipid profiles. The
distribution of medications used provides insight into both real tolerability and efficacy of each
drug in this population.
S5-13
HIV Care: A Small Clinic Perspective
Michael Cynamon, MD1
1
Medicine, VAMC Syracuse
The HIV clinic at the Syracuse VAMC follows approximately 60 patients. Of these 50 receive
antiretroviral therapy (ART). The patients not currently on ART are stable with CD4 counts > 200
cells/µl. Ninety percent of patients on ART have CD4 counts of > 200 cells/µl and 84% viral loads
of <75 copies/ml. Those patients who do not meet the above criteria are nonetheless relatively
stable on their current regimens.
Protease inhibitors (boosted with ritonavir in 92% of patients) were the foundation for therapy in
25 patients (atazanavir 15; Kaletra 8; indinavir 1; saquinavir 1; and darunavir 1). One patient was
on both Kaletra and saquinavir. Non-nucleoside reverse transcriptase inhibitors (NNRTI) were the
base for therapy in 21 patients (efavirenz 17 [Atripla 11]; and nevirapine 4). One patient received
both Kaletra and efavirenz . Triple nucleoside regimens accounted for the remaining 5 patients
(Trizivir 2; Combivir plus tenofovir 2; and tenofovir, lamivudine plus stavudine 1). One-half of the
patients on ART were on a tenofovir containing regimen.
Long term control of HIV infection should be achievable with currently available agents. The
primary cause of morbidity and mortality facing this population of patients is liver failure or
hepatocellular carcinoma due to chronic hepatitis C infection.
S5-14
LDL: How Low Is Too Low?
Nicole Dolder, PharmD1, Charles de Comarmond, MD2
1
Pharmacy, VA Salisbury, 2Infectious Disease, VA Salisbury
We will review the hypercholesterolemia history and explore treatment options of a 45 year old
HIV positive male. This patient was diagnosed with HIV in 1990 and also suffers from insulin
dependent diabetes, hypertension, and obesity. This patient’s triglycerides have been elevated
for most of the past seven years, reaching levels beyond 5000 mg/dL while on HIV regimens
containing one of the following three protease inhibitors: indinavir, nelfinavir, and lopinavir. The
patient has a K103N mutation conferring resistance to NNRTI. These elevated triglyceride levels
persisted despite hypercholesterolemia treatment including a combination of ezetimibe 10mg
daily, atorvastatin 80mg daily and gemfibrozil 600mg twice daily. Following a switch in his HIV
treatment from lopinavir/ritonavir to atazanavir/ritonavir and maintaining an NRTI backbone, the
patient’s cholesterol panel showed a substantial improvement in triglyceride levels (currently 297
mg/dL), however his LDL level is 13 mg/dL. The efforts to decrease his risk of a persistently
elevated triglyceride level have led to what would be considered below normal LDL levels.
Information collected from a literature search will be presented to discuss current data regarding
LDL levels below what is considered the normal therapeutic range.
S5-15
Delivery of Clinical Pharmacist Services (CPS) into a High Risk OB/GYNE
(HROBG) Clinic
Rupali Jain, PharmD1, Doris Carroll, BSN2, Mariela Diaz-Linares, PharmD1, Ronald Hershow,
MD3, Mark Vajaranant, MD4
1
Pharmacy Practice, University of Illinois at Chicago, 2College of Medicine, Section of Infectious
Diseases, University of Illinois at Chicago, 3University of Illinois at Chicago, School of Public
Health, 4Obstetrics/Gynecology, University of Illinois at Chicago
Purpose: To describe CPS developed and provided in a High-Risk OB/GYNE clinic.
Methods: The HROBG clinic was developed and integrated within existing HIV clinics to promote
women’s health screening and prenatal care in patients. The HROBG clinic sees approximately
30 pregnant women annually. The number of HIV pregnant women and their complexity of care
provided have increased over the years; therefore CPS was incorporated into the clinic. A
multidisciplinary team (MDT) approach is used, consisting of physicians (Infectious Diseases, and
Obstetrics/Gynecology), nurses, research personnel, a clinical pharmacist, a social worker, and
patient advocates. CPS was developed to promote patient education, monitor adherence and
antiretroviral therapy (ART). CPS also helps with ART management by reviewing resistance
testing, assisting with selection of ART, managing adverse drug reactions and drug interactions,
and evaluating safety during pregnancy and the need for Therapeutic Drug Monitoring. CPS also
helps ensure access to medications by coordinating AIDS Drug Assistance Program (ADAP)
medications and refills. Additionally, a subset of patients will have routine visits for pillboxes as
part of a formal adherence program. Pharmacists are actively involved in a weekly MDT
conference where patient’s records are reviewed and therapeutic recommendations are made.
Conclusion: The incorporation of CPS into the HROBG clinic has been well accepted by both the
care providers and the patients in an era of increasing complexity of care. The CPS in HROBG
clinic will be collecting data to support continued inclusion into the clinics and will pursue external
funding from various sources.
S5-16
The Indian Health Service's HIV Case Management System
Theresa Cullen, MD1, Cynthia Gebremariam, RN1
1
Office of Information Technology, Indian Health Service
The Indian Health Service (IHS) is committed to providing appropriate information technology
tools to diagnose, monitor and effectively case manage health care problems that are confronting
American Indian/ Alaska Native (AI/AN) communities and populations. The Resource and Patient
Management System (RPMS) is the agency’s health information solution and includes a suite of
over 60 software applications.
In response to tribal and end user input, the IHS developed an HIV case management software
application that facilitates the identification and appropriate management of people “at risk” for or
living with HIV/AIDS. The software was developed with subject matter experts from within the
Indian health community, as well as representatives from the Centers for Disease Control (CDC).
It was designed with both the specialist and non-specialist provider in mind.
A key feature of this software is the “auto- search” of the site’s database for people living with
HIV/AIDS based on diagnosis, labs and medications. Once identified, register status is decided
on by a clinician. Patients on the register will benefit from the incorporation of artificial intelligence
algorithms to generate HIV-related reminders to assist providers in proactively managing the care
of their patients. These reminders include: lab tests, STD screenings, immunizations, education
needs, and other exams. Individual as well as population reports are available, including a report
that reflects compliance with quality of care standards.
The goal is to provide a tool that will facilitate both a holistic approach to the care of this
population and an improvement in quality of health care delivery.
S5-17
Amelioration of Human Immunodeficiency Virus (HIV)-Associated
Neuropathic Pain with Spinal Cord Stimulation (SCS): Case Reports
Gary Thomas, MD1, Allison Foster, PhD2
1
Comprehensive Pain Management, New York, NY, 2Boston Scientific, Valencia, CA
Introduction: A common neurological complication of HIV infection is painful sensory neuropathy
of the extremities which can result from antiretroviral drug toxicity. Pain relief from medications
and other techniques is often inadequate; thus, physicians need other options in their
armamentarium for these difficult-to-treat patients. Here, we describe five patients who found
successful relief of their pain with SCS therapy.
Methods: Histories, treatments, and outcomes were gathered from retrospective chart review.
Case Reports: Patients were males (30-40) with histories of intractable HIV-associated distal
lower extremity neuropathy. Despite the use of opiates and anticonvulsants, the pain was
unbearable and for some patients approached 10 on a 0-10 scale of severity. All were implanted
with bilateral 8-contact epidural percutaneous leads at T9 and a rechargeable pulse generator
(Precision™, Boston Scientific) after a successful trial period, according to standard medical care.
With SCS therapy, patients reported substantial pain relief, in some cases as high as 70%.
Additionally, patients were able to reduce their pain medications and were better able to walk and
return to work.
Discussion: All patients in this report had exhausted conventional pain management options for
their HIV-associated neuropathy and were thus ‘rescued’ by SCS therapy. Because SCS therapy
is minimally invasive, reversible, and can be tested for efficacy prior to permanent implantation, it
represents a viable non-drug option for patients who face significant challenges due to their pain.
Based on the excellent outcomes of these patients, we encourage the consideration of SCS for
the management of HIV-associated neuropathy.
S5-18
Changing Lives with a New Attitude
Karen Gordon-Boyle, MD1, Barbara Cicatelli, Jairo Pedraza, Jocelyn Dow
1
Technical, the Guyana HIV/AIDS Reduction and Prevention Project
“A New Attitude” is a unique project built on the premise that affluent, business women could play
a pivotal role in linking stigmatized, indigent HIV infected women to social capital. The target
group was 30 unemployed, HIV infected women in need of economic empowerment.
The Objective was to change the attitude of the women, from one of passive bystander, to that of
a pace setter.
The women were placed at two businesses after workers there had been sensitized. They were
taught new skills in craft, self awareness, managing their significant relationships and small
business management. Eventually the women would either be absorbed into the work force or
work from home supplying products to the same businesses. They are assured of markets
through those of the established businesses the women are attached to.
The project has assisted participants in accessing micro financing to start their own micro
enterprise. One such woman, Marjory, orphaned at the age of five and introduced to prostitution
by her step mother was unable to read or write when she started the project. Marjory found a
new family on the project and was linked to a community reading program. She felt so
empowered that left her life of prostitution and accessed the micro financing initiative to start her
own business. She has been servicing her loan promptly and when asked how she felt about
having her own business she said “I feel like a million dollars.”
S5-19
How Physicians are Using the Federal Treatment Guidelines: Data from
AIDSinfo's Online American Customer Satisfaction Index Survey
Cynthia Cadden, MSN1, Robb Heier, PhD1, Gale Dutcher, MS2, Cynthia Love, MS2
1
AIDSinfo, 2National Library of Medicine
Treatment of HIV infection is complex, requiring combination therapy of drugs with different
antiretroviral potencies and toxicities. The federal government has developed a series of
treatment guidelines, providing a standard of care for managing HIV infection specific to various
populations.
The AIDSinfo Web site (AIDSinfo.nih.gov) is the primary dissemination point for these guidelines,
linking the work of the expert panels to users seeking information. In 2006, AIDSinfo reported that
a total of 3,409,112 PDF files of guideline documents were downloaded.
To collect information on guideline users, AIDSinfo posted the American Customer Satisfaction
Index (ACSI) survey on guideline pages. From December 2005 through December 2006, a total
of 1,245 surveys were completed with physicians (N=510) responding to questions about how
frequently they access guideline information and how they use guidelines, as well as offering
suggestions for guideline improvement.
Physicians reported using the guidelines to: review the current knowledge on HIV/AIDS (80%),
get the latest treatment information (67%), make decisions about patient care (55%), and to
confirm decisions about patient care (50%). Physicians also reported using the guidelines for
professional development, to develop materials for presentations, and to obtain patient education
information.
The frequency of physician visits to the guidelines pages showed a pattern similar to an earlier
AIDSinfo online survey (2002) that reported physicians with >50 patients accessing guideline
information more frequently than physicians treating fewer patients.
The treatment guidelines serve a role in informing physicians about standards of care, and
AIDSinfo is an important service to disseminate those guidelines.
S5-20
"Utilization of the Clinical Case Registry, as an Outcome Indicator, in a
Medication Adherence Program"
Karen W. Cervino, RN, MS, ACRN and Janet C. Novak, RN, MA, ACRN, VAMHCS, Baltimore,
MD
Introduction: The Treatment Initiation Clinic (TIC) was started as a quality improvement activity in
response to suboptimal treatment outcomes. Program goals are to provide education and
support for patients and discuss the impact of Antiretroviral Therapy (ART) adherence for
improved outcomes.
Methods: Infectious Disease providers are encouraged to refer all patients starting or switching
ART to the TIC. Medication adherence education is started immediately and continues
throughout each visit. Viral loads are usually performed every two weeks after starting ART.
Once viral suppression (viral load < 75 c/mm) is achieved, viral loads are typically done every
three months.
Results: A local field in the Clinical Case Registry, that identifies viral loads within specific time
periods, was created for TIC patients. Monthly review of viral loads identifies TIC patients with
continued viral suppression and facilitates prompt intervention with those with increasing viral
loads. Measured viral loads of TIC patients on ART greater than three months, from 7/1/06 –
12/31/06, revealed 84 % (52/62) of ART naïve and 74% (87/126) of experienced patients
achieved viral suppression. Overall, 74% (139/188) of all TIC patients tested during this period
had undetectable viral loads.
Conclusion: The Clinical Case Registry is a powerful tool which can be utilized to identify patient
outcomes. Monthly reports, such as viral loads, facilitate timely interventions with patients to
prevent resistance and promote adherence and viral suppression. The Clinical Case Registry
also provides information regarding demographics, co-morbidities, medication usage, and other
descriptive data.
S5-21
Abstract On Daily Cotrimoxazole Prophylaxis in Pediatric HIV Infection
Anuja Bandyopadhyay, MBBS1
1
Medical College, Kolkata
EFFECT OF DAILY COTRIMOXAZOLE PROPHYLAXIS ON THE
MORBIDITY AND MORTALITY PATTERN OF HIV INFECTED CHILDREN IN EASTERN INDIA.
Objective: Although JOINT/WHO/UNAIDS/UNICEF has advocated cotrimoxazole (CTMX)
prophylaxis as a part of their guideline for early care and treatment of HIV infected children, not
much work has been done in our local settings regarding the efficacy of the prophylaxis. CTMX
can improve survival independent of anti retroviral drugs, hence making it important. This study
was directed to evaluate the success or failure of this cost-effective prophylaxis strategy in a
resource constrained locale.
Methods: Retrospective cohort study was conducted in the Apex Clinic, MCH, Kolkata on 50 HIV
positive children. Retrospective data on the incidence of frequent episodes(>2 episodes in any 2
consecutive months) of RTI, diarrhea, oral candidiasis and skin lesions, incidence of TB,
hospitalization and death before and after onset of daily cotrimoxazole prophylaxis(6-8mg/kg
body weight) was collected, both for 1 yr, from clinic register.
Results: There was a reduction of frequent opportunistic illnesses like RTI in 28% patients
[p<.001, CI=0.4186-0.1268], diarrhea in 24% patients [p<.025, CI=.3661-.0429], TB in 8%
patients [p<.005, CI=-.0510- -.2672], after initiation of cotrimoxazole prophylaxis. There was no
significant reduction in occurrence of oral candidiasis, recurrent skin lesions, hospitalization and
mortality rates.
Conclusion: Daily cotrimoxazole prophylaxis causes significant improvement in morbidity of HIV
infected children. It might not be a radical cure, but it definitely provides relief to the patients, as
well as slows the process of deterioration of health in these vulnerable children. In our resourcelimited settings, despite all the financial constraints, cotrimoxazole, coupled with maintenance of
proper hygiene and nutrition, provides a means of improving morbidity in an otherwise helpless
condition. With HIV, spreading like wild fire, future work on these topics is the need of the hour.
S5-22
Recent Drug Use, Homelessness and Increased Short-term Mortality in
People with HIV and Alcohol Problems
Alexander Walley, MD1
1
Boston Medical Center
Objective: To determine the short-term mortality impact of recent heavy alcohol use, heroin or
cocaine use and homelessness in HIV-infected persons with alcohol problems.
Methods: We studied mortality in a cohort of 595 HIV-infected persons with alcohol problems
who were assessed at 6-month intervals 1996-2005. Main independent variables were: heavy
alcohol use (past 30 days), heroin or cocaine use (past 6 months), and homelessness (past 6
months). We analyzed variables as time-varying in Cox proportional hazards models and limited
the outcomes to deaths occurring within 6 months of assessment. Covariates considered in
adjusted models included age, sex, race/ethnicity, CD4 count, anti-retroviral therapy (ART),
depressive symptoms, and injection drug use (IDU) ever.
Results: Over a mean follow-up of 2.7 years, 31 subjects (5.2%) died within 6 months of last
study assessment. Characteristics at study entry included: mean age 41 years; 25% female; 41%
African-American; 24% with CD4 count <200; 41% not on ART; 30% heavy alcohol use; 57%
heroin or cocaine use; and 28% homelessness. Heroin or cocaine use (hazard ratio (HR) 2.20
[95% confidence interval (CI): 1.03-4.73]) and homelessness (HR 2.75 [95%CI: 1.25-6.03]), but
not heavy alcohol use (HR 0.93 [95%CI: 0.41-2.12]), were associated with increased mortality in
analyses adjusted for age, IDU ever, CD4 count, and current ART.
Conclusions: Recent heroin or cocaine use and homelessness are associated with increased
short-term mortality in HIV-infected patients with alcohol problems. Optimal treatment for HIV
patients should include regular assessments of drug use and homelessness and access to drug
treatment and housing.