Download HIV-NAT:

HIV-NAT: Promoting clinical
research and rational use of
antiretroviral agents in Thailand
ART access in resource limited settings
• AIDS progression and mortality in lessdeveloped countries continues to rise
• Causes:
– Access to antiretroviral therapy (ART)
– Poor access to voluntary counselling and
testing
– Limited public health infrastructure to support
diagnosis and monitoring
– Lack of trained staff to deliver services
HIV-NAT History
• HIV-Netherlands-Australia-Thailand
Research collaboration established 1996
• Aims:
– to conduct clinical research into ART
– to develop and promote appropriate and
affordable treatment strategies for people
with HIV in Thailand and neighbouring
countries
Research questions in resource
limited settings
1.
2.
3.
4.
5.
Can ‘state of the art’ clinical trials be successfully
conducted?
Can HIV disease progression be retarded to the
same degree as achieved in developed countries?
Can strategies be developed to maintain ART for
clinical trial participants after the trials have ended?
How can a clinical research network successfully
build local capacity and inform local policy
development?
Are intensive monitoring strategies required in
settings with considerable economic constraints?
HIV-NAT Trials
• HIV-NAT trials have been consistent with Thai
National treatment guidelines
• Clinic visits are conducted at least 3 monthly:
– history and physical examination, assessments of
disease progression and ART toxicity
– Blood collection for immunological, virological,
haematological and biochemical tests
– Adherence counselling
• Early protocols HIV-NAT initiated
• Subsequently participated in multicentre trials
Prepared by John Liddy, HIV-NAT
HIV-NAT drug fund
NNRTI failure
015
STUDY TIMELINES at HIV-NAT
014
013
Adult studies
012
SPD
Pediatric studies
011
HIV-NAT 006
Completed studies
STACCATO
HIV-NAT 010
HIV-NAT 009
d4T ER
Atazanavir
HIV-NAT 005
004 Vanguard
ESPRIT
T-20 PK
HIV/Hep B/C
2NN
Decadurabolin
007
003 series
002 series
001 series
1996
March 2004
1997
1998
1999
2000
2001
2002
2003
2004
HIV-NAT outcomes (1)
• Process measures (March 2004):
– 20 trials completed, 14 in progress
– >1,500 currently enrolled & post-trial patients
receiving ART
– Two year retention rates on clinical trials are greater
than 90%
• Clinical Outcome measures – 001- 005 series of trials
– Median time to follow up: 62.3 months
– 29 of 417 patients progressed to AIDS or died
– TB most common event defining progression
– Outcomes equivalent to or better than developed
world cohorts
HIV-NAT outcomes (2)
• HIV-NAT drug
– subsidized ART on a sliding scale
• Capacity and infrastructure building
– Laboratory practice
– Clinical practice
– Health personnel training
• Influence on local policy development
WHO 3 by 5 initiative
• Treatment gap declared a global
emergency in September 2003; WHO and
UNAIDS launch 3 by 5 initiative
• Target: 3 million people on ART by 2005
• Aim: universal access to treatment as a
human right
3x5 Pillar 5
• ‘As treatment programmes go to scale, it
is critical to derive data about what works,
and what does not work, and why, as fast
as possible’
• Pillar 5
– Build on successes
– The rapid identification and re-application of
new knowledge and successes (operational
research (OR) agenda)
3x5 Operational Research Agenda
1. Coordinate and help develop an
appropriate operational research agenda
relevant to needs of ART programmes
2. Seek data on the impact of scaling up
ART on prevention and at risk
behaviour; on mitigation; on stigma and
discrimination
3x5 OR agenda (2)
3. To identify ways to define the
externalities of ART scale-up on health
systems performance
4. To identify ways to cost ART
programmes and to link costs to impact
and effectiveness
3x5 OR agenda (3)
5. To improve programme design and find
better tools to reduce risky behaviour,
the evolution of drug resistance, based
on the analysis of data
6. To incorporate new knowledge rapidly
back into ART programme policy and
practice
HIV-NAT Summary
• HIV-NAT is a successful clinical research
network, providing:
– Access to ART
– Appropriate clinical care
– Good health outcomes
– High degree of medication adherence
– Local capacity and expertise
– Improved public health infrastructure
HIV-NAT policy implications (1)
• Rational drug use (RDU):
– right drug, right patient, right indication,
right dose, right duration, lowest cost
• HIV-NAT demonstrates that RDU can be
realised and good clinical outcomes can
be achieved in resource-limited settings if
funding and resources are available
HIV-NAT policy implications (2)
• Challenge for the international community to
contribute funds, training and resources so that
– Work in resource limited settings can
continue
– ART can be delivered in a rational and
coordinated manner
– Programmes can be implemented and
broadened to reduce morbidity and ultimately
save lives
Authors/Acknowledgements
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•
•
•
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Dr Stephen Kerr
Dr Chris Duncombe
Theshinee Chuenyam
Prof Kiat Ruxrungtham
Prof Joep Lange
Prof David Cooper
Prof Praphan Phanuphak
HIV-NAT staff
The HIV-Netherlands Australia Thailand Research Collaboration (HIV-NAT)
104 Rajdumri Road
Pathumwan, Bangkok 10330
Thailand
Email: [email protected]