Download The Rockefeller University Center for Clinical and Translational

The Rockefeller University Center for Clinical and Translational Science
Minutes of the Advisory Committee on Clinical and Translational Science (ACCTS)
October 3, 2011
Voting Members Present: Robert Darnell – Chair, Ed Barbour, Iddo Ben Dov, Edgar Charles, Barry Coller,
Emil Gotschlich, Peter Holt, Lisa Hudgins, Rhonda Kost, Michelle Lowes, Marty Markowitz, Barbara
O’Sullivan, Neil Renwick, Terry Solomon, Mayte Suarez-Farinas
Invited: Donna Brassil
_______________________________________________________________________________
The meeting was called to order at 2:32 pm
_______________________________________________________________________________
1. Approve minutes from the July 20, 2011 ACCTS meeting
2. Initial Reviews
Emma Guttman
Analysis of Immune Reactions Occurring
Upon Administration of Patch Tests and
Contact Dermatitis Affected Skin
[Reviewer: Michelle Lowes]
Scientific Initial Review
What are the background and goals of study?
This is a study to understand the cellular and molecular responses of allergic contact dermatitis (ACD).
Patients suspected of having ACD will be patch tested in the outpatient clinic with 15 common
allergens, and a "no allergen" site. If there is a positive reaction, biopsies will be taken of baseline, no
allergen control and positive allergen sites. Patients will be given information for allergen avoidance.
Patients will then be able to come into the second phase of the study 2-8 weeks later, where the
positive allergen is applied in triplicate, for paired LS/NL biopsies at Day 2 and 7.
400-500 patients 18-60 years will be studied over 15 years. Patients will be paid $175 for the first
phase, $225 for the second.
If this is a clinical trial, please specify:
Intervention: N/A
Primary endpoint: Clinical evaluation of reaction to allergens
Secondary endpoint: Cellular and molecular evaluation of skin by IHC and microarray/PCR
What are the major risks?
Moderate risk: rash at site of reaction; risks of biopsy and blood draw
1
Statistical Analysis (optional: comments in addition to Biostatistician review)
What is the potential significance of the study?
It will be interesting to understand more about the process of ACD.
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
High
Moderate
Moderate
Recommendation
Reviewer's Recommendation of Submission
Approve
Reviewer's Comments
Although this is a research protocol, there will be both a clinical results and research data. The clinical
patch test results will be given to the patients by Dr Guttman, a board-certified dermatologist, as well as
information on how to manage the allergy. This is written in the consent form and this approach is the
standard of care for diagnosis and management of ACD.
No patients with suspected occupational allergies will be studied- the allergens chosen are not
commonly encountered in occupational allergy, and additional allergens pertinent to occupational
exposure will not be added. This could be added to the inclusion/exclusion criteria.
Indication of Review Completion
Yes Date the Review was completed: 09/30/2011
Enter DSMP Review:
Comment:
1. Dr. Guttman directs the dermatology clinic and plans to refer patients from the clinic and from
her own practice. In order to minimize the therapeutic misconception and assure voluntariness,
the consent form and consent process should explicitly address the distinction between regular
care and research care. This can be confusing since patch testing is part of regular care and
diagnosis in ACD, and it should be clear that patch testing undertaken at Rockefeller, is part of
research care.
2. The protocol describes contact dermatitis causing intense pruritus through contact dermatitis
that may "affect the quality of life", yet the study plan involves application of 15 common
potential allergens to enhance the likelihood of achieving the target inflammation. The likelihood
of multiple reactive test allergens, and the total number of biopsies, raise concerns both about
the likelihood of successfully recruiting participants for merely $25 per allergy panel, and the risk
that participants will not return for the second round of testing once they have undergone patch
testing and multiple biopsies.
3. The protocol should address what measures the participant can undertake to minimize the
discomfort of exuberant and/or multiple reactive test patch sites and the impact of those
measures on biopsy healing and protocol retention. A participant might seek relief for
2
extremely itchy and uncomfortable test patches; presumably the application of topical
corticosteroids would interfere with healing of biopsy sites and might interfere with the integrity
of the immune response for stage 2. Please include discussion of managing this 'toxicity' both
in approach and impact.
Recommendation
Reviewer's Recommendation of Submission
Approve with recommendations
Reviewer's Comments
Recommend:
1. Revise ICF to emphasize the distinction between care and research; allergy panels alone can
be part of routine care, but allergy panels conducted at Rockefeller coupled with biopsies, are a
research activity.
2. Describe what measures, if any, a participant may use to alleviate intense discomfort/itching
associated with exuberant patch test reactions, and whether use of those measures would
terminate protocol participation for stage 2; address whether participants will be made aware of
these care options.
3. Revisit the compensation scheme soon after recruitment begins; the current compensation
levels are not likely to be adequate for achieving the designated sample size.
Martin Markowitz
The STOP Project-Screening Targeted
Populations to Interrupt On-going Chains of
HIV Transmission with Enhanced Partner
Notification
[Reviewer: Edgar Charles]
Scientific Initial Review
What are the background and goals of study?
The goal of the project is to evaluate acute HIV infection (AHI) screening programs linked to enhanced
partner services (contact tracing and partner notification services).
The STOP Study will compare two methods (4th generation EIA and pooled NAAT) to detect AHI. The
STOP Study will also compare the benefit (in terms of new HIV infection detected among partners) of
enhanced partner services (performed by a specialist experienced in locating contacts through media
such as on-line chat rooms) provided to index cases with AHI and with established HIV infection.
Briefly subjects will be studied at community health clinics in San Francisco, North Carolina, and NYC.
HIV testing with 4th generation EIA and/or NAAT will be performed. Tracing and notification of sexual
contacts of AHI individuals will be performed either using "standard of care" or an "enhanced" strategy,
as alluded to above.
If this is a clinical trial, please specify:
Intervention: N/A
Primary endpoint:
3
1) Evaluation of the number of individuals with AHI detected with the 4th generation EIA compared with
pooled NAAT.
2) The number and proportion of partners with newly diagnosed HIV infection detected with enhanced
partner services among index cases diagnosed with AHI compared with partners of persons newly
diagnosed with established HIV infection.
Secondary endpoint:
1) Evaluation of whether molecular phylogenetic techniques confirm transmission networks identified
with enhanced partner services.
2) Evaluation of the cost-effectiveness of screening for AHI with 4th generation EIA compared to pooled
NAAT.
What are the major risks?
The study poses no more than minimal risks to subjects, who are giving their consent for HIV infection
and have agreed to partner services. Molecular testing will be done on de-identified samples.
Statistical Analysis (optional: comments in addition to Biostatistician review)
Defer to biostatistician
What is the potential significance of the study?
The study could establish whether 4th generation EIA or pooled NAAT is more effective at diagnosing
EIA, and whether using enhanced partner services to trace and notify sexual contacts is effective at
preventing HIV transmission.
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
Moderate
Moderate
Low
Recommendation
Reviewer's Recommendation of Submission
Approve, exempt from Review
Reviewer's Comments
This study poses no more than minimal risk to subjects, as described above, and should be exempt
from review.
Martin Markowitz
A preclinical assessment of GSK1265744,
and InSTI, as PrEP
[Reviewer: Edgar Charles]
Scientific Initial Review
What are the background and goals of study?
4
Recent randomized controlled trials have demonstrated the efficacy of tenofovir alone or tenofovir and
3TC as pre-exposure prophylaxis (PrEP) in the reduction of the risk of HIV transmission. While certainly
a milestone, there is a clear need to study the use of other antivirals as PrEP agents. This study aims to
assess the in vitro susceptibility of a diverse panel of transmitted HIV-1 variants to GSK1265744, with
the goal of determining whether this compound is a suitable PrEP candidate.
Methods:
a) The PI will assemble a panel of 36 transmitted HIV-1 isolates including representatives of Clades A,
B and B’, C, D, G, CRF01_AE, CRF02_AG, CRF07_BC, and CRF_BF. Susceptibility defined as the
IC50 and IC90 to GSK1265744 in vitro using human peripheral blood mononuclear cells will be
measured.
b) Viral isolates or PBMC to expand isolates will be derived from 3 sources:
1. Stored PBMC in the freezers at ADARC that were collected under study MMA-465. All
participants gave permission for the storage and subsequent use of these PBMC by signing
informed consents.
2. Viral isolates from African sites for the Study CHAVI001 in which ADARC participated as a US
site (MMA-639). All patients will have signed consents to store and share PBMCor isolates.
Specimens will be coded and the ADARC team will not be able to link specimens with individual
patients.
3. Viral isolates from China will be deidentified viral isolates or peripheral blood mononuclear cells
from Asian sites located in multiple provinces where HIV/AIDS are the most severe.
c. Viral isolates will be expanded from provided culture isolates or peripheral blood mononuclear cells
(PBMC) from newly infected individuals on PHA-stimulated uninfected PBMC in IL-2 containing media
as published.
d. Culture supernatants will be subtyped as per published methods and the integrase coding region
sequenced.
e. Expanded viral isolates will be tittered on PBMC as published and used for susceptibility assays and
a minimum of 3 isolates conforming to each of the subtypes noted above will be tested for susceptibility
to 744.
f. For each isolate 7x106 PHA-stimulated, CCR5 wild type uninfected PBMC in a volume of 2.5 ml will
be incubated with virus at an MOI of 0.1 for 2 hours at 37C and washed and plated on a 96-well plate
with 5-fold dilutions of 2x-744 ranging 0.02nM to 50nM (final concentration 744 0.01nM to 25 nM) and a
no drug control Final concentration of PBMC will be 2x106/ml. Cultures will be maintained as published
and p24 antigen levels will be measured at day 10 and cultures will be maintained to day 21. All assays
will be done in duplicate. IC50and IC90 will be based on p24 Antigen concentrations in the absence and
presence of drug and determined using Prism.
If this is a clinical trial, please specify:
Intervention: N/A
Primary endpoint: IC50 and IC90 of isolates.
Secondary endpoint: None
What are the major risks?
As the study will utilize previously-collected, de-identified plasma and PBMCs, it poses no significant
risks to human subjects.
5
Statistical Analysis (optional: comments in addition to Biostatistician review)
Defer to biostatistician.
What is the potential significance of the study?
As mentioned above, there is a need to identify other PrEP agents that might be more efficacious in
preventing the transmission of HIV. This study would provide data that would either support or disfavor
the further investigation of GSK1265744 as a PrEP agent.
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
Recommendation
Moderate
Moderate
Low
Reviewer's Recommendation of Submission
Approve with stipulations
Reviewer's Comments
As the study proposes to utilize previously-collected, de-identified plasma and PBMCs, it poses no
significant risks to human subjects, and should be exempt from review according to Category (4).
However, the term "InSTI" included in the protocol's title is not mentioned in the protocol itself. The PI
needs to clarify what “InSTI” is. Since it does not appear in the protocol, it should either be deleted from
the title of the study, or if the PI wishes it to be included, the protocol should be revised accordingly.
Indication of Review Completion
Yes
No
Date the Review was completed: 10/11/2011
Bernice Rumala
Evaluation of SPARC Initiatives
[Reviewer: Michelle Lowes]
Scientific Initial Review
What are the background and goals of study?
SPARC stands for the Achieving Successful and Productive Academic Research Careers (SPARC), a
tri-institutional initiative to engage minorities in science. Bernice Rumala wants to conduct an
anonymous survey to 5000 people over 5 years.
If this is a clinical trial, please specify:
Intervention: nil
Primary endpoint: complete evaluation data to assess the impact of the SPARC initiative, the views and
needs of the participants
6
Secondary endpoint: N/A
What are the major risks?
NIL
Statistical Analysis (optional: comments in addition to Biostatistician review)
What is the potential significance of the study?
May be helpful
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
High
Moderate
Low
Recommendation
Reviewer's Recommendation of Submission
Approve
Reviewer's Comments
Indication of Review Completion
Yes Date the Review was completed: 09/30/2011
DSMP Review
Enter DSMP Review:
Comment:

Potential issues are – exclusion of minors, confidentiality, and survey data quality.
Minors



Repeat banner, “DO NOT COMPLETE IF YOU ARE <18 years old” both at the top of the first
page, and near the age question box. Describe how you will assure that when audiences are
mixed, minors do not contribute data?
Provide a text box at the top of the form for respondent to fill in the date of the event - some
events involve many more minors; excess data from a mostly-minors event would indicate that
the written prohibition was not working. This is also needed to align the data with the
appropriate event.
Consider proposing and submitting an amendment that would allow for parental consent and the
participation of minors in the research evaluation portion of the program.
7
Confidentiality – is adequately addressed with anonymous survey design.
Survey data quality – The survey would benefit from another round of refinement. For example:



The federal categories for Race are not always consistent, note the 2000 and 2010 Census
categories, however it is common practice to offer “some other race” or “2 or more races”, and
to offer “decline to answer” rather than asking “other (specify).”
Some questions inherently assume that the participant has internalized a concept from the
conference, such as asking about a ‘science mentor’ or a ‘research network’. These questions
could be re-constructed to ask whether the participant 1) now understands what a science
mentor is, 2) could now identify a potential science mentor from among his/her teachers and
other contacts, or 3) has identified a new potential science mentor from the conference
attendees.
Some of the questions asking “as a result of the conference” seem very leading and could be
rewritten to explore change of state or change of ideas without so clearly assigning causality at
the asking. Co-Coded before and after evaluations might be a better way to get at some of the
issues.
Recommendation
Reviewer's Recommendation of Submission
Approve with recommendations
Reviewer's Comments
Add age warning banner near age-related question on survey
Add date of event/evaluation to top of survey to align data with event
Develop process to cross check that minors are not submitting evaluations anyway
Develop amendment/protocol to include minors as they are a key target audience.
Consider revision of survey questions for clarity and neutrality.
Nicholas Schiff
Neurological
Neurophysiologic Studies of
Disorders of Consciousness
[Reviewer: Emil C
Gotschlich]
Scientific Initial Review
What are the background and goals of study?
This study is designed to intensively observe patients in the minimally conscious or confusional state
for a period of about 4 days at the Rockefeller University Hospital. The technologies that will be
employed are continuous video monitoring combined with EEG, one PET scan with fluoro deoxy
glucose and a fMRI session. The overall plan is to do this with 80 patients at the rate of about 12
patients per year. The patients will be recruited from long-term care facilities with which the
investigators have established relationships. Particularly in the initial phases of the study there will be
close quality control of the capability of the Rockefeller University hospital to provide the extensive and
highly specialized care that such patients require and this is listed in detail in section 8.5 under the
secondary outcomes.
On day 0 the patients will be seen in the outpatient clinic for a medical history and physical examination
and a thorough neurological and/or psychological examination plus a baseline EEG to establish that
there is no seizure activity.
8
Day 1 - 3 will include continuous video the EEG monitoring, neurological and neuropsychological
examinations, and behavioral studies. In addition on day 3 PET scan will be performed and on day 4 an
fMRI MRI study.
A cohort of normal healthy individuals would be included that will have the same screening examination
and then on an optional basis a MRI and an overnight sleep study with continuous video and EEG
monitoring.
The Hypothesis is that Physiologic measures of brain function can be tracked and will correlate with
recovery of cognitive function after severe brain injury.
If this is a clinical trial, please specify:
Intervention: This is not a clinical trial
Primary endpoint: The primary outcome will be the Association of measured brain assessments (fMRI,
EEG, PET) to the changes in behavioral quantitative measures over time. The fMRI and the EEG will
be done with the patients presented with tasks of increasing complexity which are outlined in section
8.7 Data analysis.
Secondary endpoint: The adequacy of the care and support provided to the patients during their stay at
RUH
What are the major risks?
There are no major risks in this study
Statistical Analysis (optional: comments in addition to Biostatistician review)
The methods used to analyze the data obtained by these modalities is described in their revised data
plan and in the reprints that there submitted as part of the submission.
What is the potential significance of the study?
The significance of this study is that it will add knowledge to the as yet poorly understood
neurophysiological processes involved in recovering from severe brain injuries a problem that is
unfortunately very common in young individuals and increasingly so in military personnel exposed to
blast injuries.
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
High
High
High
Recommendation
Reviewer's Recommendation of Submission
Approve
Reviewer's Comments
Indication of Review Completion
Yes Date the Review was completed: 10/03/2011
9
DSMP Review
Enter DSMP Review:
Application Section and comment:








7.2, 7.3: response incorrectly states that NYH/WCMC are not involved in the study; protocol is
conducted in collaboration with NYH/WCMC investigators
8.9 indicate that no samples will be collected; yet the collection of venous blood for genotyping
is described in section 8.6. Need correction.
9.3; 80 subjects seems like a high number for a feasibility study; if this is a smaller n pilot,
within a planned 80 subject study, clarify as such.
11.2; states consenting may take place long term care facilities. What assurance is necessary,
or collaboration or permission from that institution is necessary? Need to avoid therapeutic
misconception; how does the doctor primarily responsible for the patient’s care factor in? Are
Dr. Fins and Dr Schiff on staff at the LTC facilities? Also, who will review the appropriateness of
the designated LAR, or any documentation of the LAR status? How will the legitimacy of the
LAR be documented prior to considering the IC valid? RU OGC?
11.5 is incoherent/ please correct
12.3 does not describe at all how participants will be identified and/or recruited to the study.
Referral? Advertisements at LTC facilities? Recruitment from the ICU/medical floor? This
section is incomplete.
16.1; the point of the question is alternative to participation in terms of opportunity cost; an
appropriate answer here would be to address any treatment options that the participant is
foregoing while participating in the study (rehabilitative care at a LTC facility; absence of
definitive treatment).
23.4 – given the list of equipment, it seems there will be storage needs. Defer to research
nursing and administration.
ICF For healthy volunteers:

Remove the italicized instructions to the PI in the certificate of confidentiality section
ICF For affected participants:





Section II states ‘you will be screened in the Outpatient Clinic…” Is this correct, for a bed-bound
minimally conscious person? It seems inappropriate for the OPU setting. Won’t they be
screened on the IPU, though not admitted, like a Day patient?
The procedures section does not mention the tube of venous blood that is noted in the
protocol. Please reconcile.
Remove the instruction to the PI in the Certificate of Confidentiality section.
The language about what type of care, and for what conditions will and will not be provided
appears to be missing
The language about ‘no cost to you’ should be modified to explain that if a usual care issue
arises, they might be transferred for care that they will be financially responsible, even though it
arose contemporaneously with research participation.
Recommendation
Reviewer's Recommendation of Submission
10
Approve with stipulations
Reviewer's Comments
Recommend:
1. A careful read through of the protocol for minor corrections to sections, 7, 8, 9, 11, 16, and 23
as detailed in DSMP review above.
2. A clear explanation of how participants and their LAR will be identified and recruited (section 11)
and where the informed consent discussions can take place (section 12).
3. Corrections to the ICF for affected participants as above in DSMP review.
Indication of Review Completion
Yes Date the Review was completed: 10/01/2011
Ana Tuyama
Gene and MicroRNA Expression Profile of
Hepatocytes and Hepatic Stellate Cells from
Obese Patients in Defined Stages of NonAlcoholic Fatty Liver Disease
[Reviewer: Peter Holt]
Scientific Initial Review
What are the background and goals of study?
Background: Nonalcoholic fatty liver disease (NAFLD) is the commonest cause of chronic liver disease
occurring in most morbidly obese individuals that can lead to cirrhosis and eventually the need for liver
transplantation in the Unites States. NAFLD is divided into hepatic steatosis or nonalcoholic
steatohepatitis (NASH) characterized by inflammation and the development of fibrosis. There is no
current effective therapy except weight loss for this disorder. The key mediator appears to be activation
of hepatic stellate cells (HSC), but the mechanism that is responsible for the switch from simple hepatic
steatosis to steatohepatitis is not known. GWAS studies, generally, have been unhelpful and gene
expression studies have to date been performed only on whole liver specimens.
Study Aims: The aim of this study is to isolate hepatocytes and hepatic stellate cells from surgical liver
wedge or biopsy specimens taken from patients undergoing obesity surgery at New York University
Hospital by 1 surgeon and to perform microarray and micro RNA array studies on isolated cells
appringed from these livers. Overall, these studies would primarily compare gene expression in hepatic
stellate cells and hepatocytes from patients with simple steatosis and with NASH to gain insight on
possible molecular mechanisms underlying this switch and subsequent progression to cirrhosis.
Methods: This is a cross sectional single center study at NYU School of Medicine with up to 30 male or
female subjects 30-60 years of age with a BMI > 35 who will be enrolled in order to find 5 subjects with
simple steatosis and 5 subjects with NASH. Once these 10 subjects have been recruited no further
subjects would be sought.
Inclusion Criteria: BMI > 35, and evidence of the metabolic syndrome on the basis of hyperglycemia or
increased fasting insulin levels plus hypertension, hypertriglyceridemia or enhanced waist
circumference.
Exclusion Criteria: Presence of evidence of other liver diseases, alcohol intake > 20g per day for
women and >30g per day for men and medications that are associated with liver dysfunction.
11
At the time of surgery and at the surgeon’s discretion a liver wedge or surgical needle biopsy will be
collected and processed immediately by the PI within the operating room permitting standard
histological evaluation by a single expert pathologist. A small sample of remaining tissue will be
embedded in OCT for later cryo-sectioning and the remaining liver tissue will be perfused and digested
with collagenase B using a standardized protocol for separation of hepatocytes and hepatic stellate
cells using a Percoll-density centrifugation gradient. Subsequently, total RNA will be isolated from the
cellular sub factions and specificity analyzed by QPCR for albumin as a marker of hepatocytes and
GFAP and alpha smooth muscle actin for HSC. RNA samples will be processed in The Rockefeller
University Genomics Facility amplified, hybridized and evaluated by Illumina-Chip and the Agilent-Chip
from micro RNA array and scanning.
In order to evaluate the effect of the cell isolation system on gene and MIRNA expression laser capture
micro dissection will also be performed to separate hepatocytes and HSC’s. Such laser capture
methods are used routinely in the laboratory of Dr. Fisher at NYU.
Principal Investigator initiated
Single Center study
Scientific Review
Major risks Bleeding from biopsy site or leak from puncture of biliary radicles
Statistics none for this pilot study
Significance Better understanding of the mechanisms responsible for the switch from simple steatosis
to NASH
If this is a clinical trial, please specify:
Intervention:
Primary endpoint:
Secondary endpoint:
What are the major risks?
Major risks bleeding from biopsy site or leak from puncture of biliary radicles
Statistical Analysis (optional: comments in addition to Biostatistician review)
Statistics none for this pilot study
What is the potential significance of the study?
Significance Better understanding of the mechanisms responsible for the switch from simple steatosis
to NASH
Ratings:
Scientific Merit:
Priority:
Resource Intensity:
High
Moderate
Low
12
Recommendation
Reviewer's Recommendation of Submission
Approve with stipulations
Reviewer's Comments
At the ACCT meeting it was suggested that the lab tests evaluating for other liver diseases should be
performed at NYU to simplify the transfer of abnormal data to the patient chart
Indication of Review Completion
Yes Date the Review was completed: 10/06/2011
DSMP Review
Enter DSMP Review:
Only coded samples will be received and studied at Rockefeller.
No DSMP issues identified.
Recommendation
Reviewer's Recommendation of Submission
Approve
Reviewer's Comments
No issues identified.
Indication of Review Completion
Yes
No
Date the Review was completed: 10/02/2011
3. Continuing
Marina Caskey
MAC-0682 - A Randomized, PlaceboControlled, Phase 1 Study to Evaluate the
Safety and Immunogenicity of Poly ICLC
(Hiltonol) in Healthy Volunteers
[Reviewer: Martin Markowitz]
Δ Exempted by reviewer
Ronald Crystal
RCR-0391 - The Natural History of Gene
Expression in Lung Cells of Non-Smokers,
Smokers, and Ex-Smokers in Health and
Disease
[Reviewer: Lisa Hudgins]
Δ Exempted by reviewer
13
Dana Orange
DOR-0722 - Evaluation of Immune
Activation in Rheumatoid Arthritis
[Reviewer: Michelle Lowes]
Δ Exempted by reviewer
Mina Pastagia
MPA-0677 - Eradication of Staphylococcus
Aureus from Skin Lesions Through the Use
of a Newly Developed Lytic Enzyme Called
ClyS
[Reviewer: Emil C Gotschlich]
Δ Exempted by reviewer
4. Amendment
Ronald Crystal
RCR-4440 - Evaluation of the Lungs of
Individuals with Lung Disease with
Segmental Bronchopulmonary Lung
Lavage, Bronchial Brushing, and Bronchial
Wall Biopsy
[Reviewer: Michelle Lowes]
Δ Exempted by reviewer
Ana Emiliano
EKE-0724 - Effect of Metabolic State on
Anxiety in Human Subjects
[Reviewer: Emil C Gotschlich]
Peter Holt
PHO-0735 - Pilot: Obesity Associated
Serum Derived Factors and Cancer.
[Reviewer: Neil Renwick]
Δ Exempted by reviewer
5. Exempt Protocols
Lindsay Lee Bellani
LDI-0731 - Pilot Study: Isolation of Cues
that Drive Mosquito Preference for
Certain Human Hosts
Jon Blumenfeld
JBL-0496 - Autosomal Dominant
Polycystic Kidney Disease Repository
Donna Brassil
DBR-0668 - A comparison of hemolysis
rates and laboratory values using
intravenous catheters versus
venipuncture for obtaining venous blood
samples
Barry S Coller
AMA-0692 - Assessment of bleeding
symptoms in individuals with bleeding
disorders using a comprehensive
Bleeding History Phenotyping System
Ronald Crystal
RCR-0391 - The Natural History of
Gene Expression in Lung Cells of Non14
Smokers, Smokers, and Ex-Smokers in
Health and Disease
Jan Davidson-Moncada
JAD-0647 - Role of microRNA's in
Lymphoma and Leukemia’s
Ronald Crystal
RCR-4439 - Evaluation of the Lungs of
Normal (Smokers, Ex-smokers, Nonsmokers) Individuals with Segmental
Bronchopulmonary Lung Lavage,
Bronchial Brushing and End bronchial
Wall Biopsy
Haiteng Deng
HDE-0680 - Crosstalk Among Oral and
Gastrointestinal Soluble Innate Factors,
HIV, and Microbes (2 Submissions)
Winrich Freiwald
WFR-0741 - The Neural Basis of Face
Recognition and Social Cognition: A
Magnetic Resonance Imaging Study
Charles Gilbert
CGI-0573 - Processing mechanisms of
visual cortex
Peter R Holt
PHO-0735 - Pilot: Obesity Associated
Serum Derived Factors and Cancer.
Lisa Hudgins
LHU-0616 - Fructose-Induced Palmitate
Synthesis in Overweight Subjects
Rhonda G Kost
RKO-0679 - Research Participant
Perception of Care Project, Part II:
Fielding and Validation of the Research
Participant Perception Survey Derived
from Focus Group-Identified Key
Dimensions of the Research Participant
Experience (with single site Cognitive
Interviewing Sub-Study)
Rhonda G Kost
RKO-0648 - Research volunteer
screening/ recruitment data repository
Ana Krieger
AKR-0102 - Mechanisms of Endothelial
Cell Dysfunction in Sleep Apnea
James Krueger
JKR-0622 - The Natural History of
Pigmented Skin Lesions
James Krueger
JKR-0686 - Screening for entry into skin
disease studies
James Krueger
JKR-0737 - Randomized Pilot Study of
Ustekinumab for Subjects with Chronic
15
Atopic Dermatitis Who Have Suboptimal Response to Prior Therapy
Dana Orange
DOR-0722 - Evaluation of Immune
Activation in Rheumatoid Arthritis
MMA-0591 - HIV Elite Controller Study
Martin Markowitz
Martin Markowitz
MMA-0577 - A Randomized Phase II
Study of Therapeutic Immunization and
Treatment Interruption Among Subjects
Who Began Potent Antiretroviral
Therapy Within 16 Days of Diagnosis of
Acute or Recent HIV Infection (AIN504)
Martin Markowitz
MMA-0754 - A Phase 2b Randomized,
Double-Blind, Double-Dummy Trial of
100 or 200 mg Once-Daily Doses of
Cenicriviroc (CVC, TBR-652) or OnceDaily EFV, Each With Open- Label
FTC/TDF, in HIV-1-Infected,
Antiretroviral Treatment-Naïve, Adult
Patients With Only CCR5-Tropic Virus
(TBR-652-2-202)
Martin Markowitz
MMA-0643 - A Phase III Multicenter,
Double-Blind, Randomized, Active
Comparator Controlled Clinical Trial to
Study the Safety and Efficacy of Once
Daily Raltegravir (MK-0518) versus
Twice Daily Raltegravir, Each In
Combination with TRUVADA, in
Treatment-Naive HIV Infected Patients
(MK-0518-071)
Martin Markowitz
MMA-0582 - A Multi-Center, DoubleBlind, Randomized, Placebo-Controlled
Study to Evaluate the Safety and
Antiretroviral Activity of MK-0518 in
Combination with an Optimized
Background Therapy (OBT), Versus
Optimized Background Therapy Alone in
HIV-Infected Patients with Documented
Resistance to at Least 1 Drug in Each of
the 3 Classes of Licensed Oral
Antiretroviral Therapies (MK-0518-019).
Martin Markowitz
MMA-0592 - The Transmission and
Fitness of Drug Resistant HIV-1 (NIH
Grant #2R01-AI-47033-06)
Martin Markowitz
MMA-0448 - Viral and Host Factors in
the Transmission and Pathogenesis of
HIV (This protocol was formerly RKO16
0201; PI has changed from Kost to
Markowitz, therefore, number was
changed.)
Martin Markowitz
MMA-0613 - A Study of the Safety,
Tolerability, and Pharmacokinetics of
KD-247, A Humanized Monoclonal
Antibody that Recognizes the Principal
Neutralizing Determinant of HIV-1 in
Asymptomatic HIV-1 Seropositive
Individuals Who Are Not Receiving
Concurrent Anti- Retroviral Therapy KD1002
Martin Markowitz
MMA-0607 - A Pilot Study of the New
York HIV Transmissions Study: Project
HITS-NY, Illicit Drug Use and Social
Network Effects Among at Risk and
Recently/Acutely HIV-1 Infected MSM
Swaroop Pendyala
SWP-0660 - Monocyte Intracellular
Cytokine Production in Healthy
Volunteers
Charles Rice
CRI-0657 - Isolation and Culture of
Tissue Culture Infectious HCV from
Blood
Sarah J Schlesinger
SSC-0710 - A randomized, placebocontrolled, dose-escalating, doubleblinded phase 1 study to evaluate safety
and immunogenicity of anti-DEC-205
monoclonal antibody (mab) targeted HIV
gag p24 vaccine (DCVax-001) with poly
ICLC (Hiltonol) as adjuvant in HIVuninfected healthy volunteers
Sanford Simon
SSI-0725 - Characterization of the
Antibody Response to Tumor
Sanford Simon
SSI-0624 - Imaging Single Molecular
Events in the Cell
Sohail Tavazoie
STA-0681 - Identification of microRNAs
that predict metastatic relapse and
sensitivity to chemotherapy in human
colorectal cancer
Leslie Vosshall
LVO-0684 - Genetic Basis of Odor
Discrimination
John Zabriskie
JZA-0540 - Natural History of
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Rheumatic Fever at Rockefeller
University Hospital
6. Reports of Director and Co-Director
Dr. Coller announced that the Center has received indications of our being awarded an additional
supplement to Dr. Tomasz and his colleague at Cornell, but no official statement has been released. He
noted that the Senate has passed the HHS appropriation of NCATS, but has also cut NIH funding. He
noted that the House proposed a budget granting the NIH a one billion dollar increase, but no funding was
provided to NCATS. Dr. Coller noted that he will send an email out once he has more information.
Dr. Coller reminded the board that the next meeting of the Therapeutic Discovery and Development
Interest Group (TD2IG) meeting is scheduled for today, Tuesday, October 4th at 4:00 pm in room 206 of the
CRC.
7. Reports of Subcommittees
A) Pilot Project and Collaborative Studies subcommittee (Edgar Charles)
Dr. Charles presented the pilots that were recommended for funding by the review committee.
– See Attached.
Motion to approve funding – Approved
B) Research Education Training and Career Development Subcommittee (Sarah Schlesinger)
No report
C) CRRF Clinical Research Resources and Facilities (Barbara O’Sullivan)
Dr. O’Sullivan informed the board that at present there is an issue regarding contracted testing.
Currently contracted testing takes up 4% of the lab budget, however as contracts expire the
costs nearly double. Dr. O’Sullivan asked the board for their advice on the matter.
Board Response – to notify PIs and request their expected usage of contracted testing for the
future as new protocols come in, to project spending.
8. Review of Center Metrics and Resource Utilization
9. Assessment of Underutilization, Inappropriate Use, and Low Productivity
10. Review of Budget
11. Strategic Planning Issues
The meeting was adjourned at 4:10 pm
Respectfully submitted,
_________________________________
Maija Williams, MPH
ACCTS Administrator
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_________________________________
Robert B. Darnell, MD, PhD
Chair
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