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HIV-NAT: Promoting clinical research and rational use of antiretroviral agents in Thailand

HIV-NAT is a successful clinical research network that focuses on promoting the rational use of antiretroviral agents (ART) and improving access to ART in Thailand and neighboring countries. This initiative aims to address the rising AIDS progression and mortality rates in resource-limited settings through conducting state-of-the-art clinical trials, building local capacity, and informing local policy development.

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HIV-NAT: Promoting clinical research and rational use of antiretroviral agents in Thailand

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  1. HIV-NAT: Promoting clinical research and rational use of antiretroviral agents in Thailand

  2. ART access in resource limited settings • AIDS progression and mortality in less-developed 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

  3. 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

  4. Research questions in resource limited settings • 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?

  5. 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

  6. Pediatric studies 1996 1997 1998 1999 2000 2001 2002 2003 2004 Prepared by John Liddy, HIV-NAT HIV-NAT drug fund NNRTI failure 015 STUDY TIMELINES at HIV-NAT 014 013 Adult studies 012 SPD 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 March 2004

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 3x5 Operational Research Agenda • Coordinate and help develop an appropriate operational research agenda relevant to needs of ART programmes • Seek data on the impact of scaling up ART on prevention and at risk behaviour; on mitigation; on stigma and discrimination

  12. 3x5 OR agenda (2) • To identify ways to define the externalities of ART scale-up on health systems performance • To identify ways to cost ART programmes and to link costs to impact and effectiveness

  13. 3x5 OR agenda (3) • To improve programme design and find better tools to reduce risky behaviour, the evolution of drug resistance, based on the analysis of data • To incorporate new knowledge rapidly back into ART programme policy and practice

  14. 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

  15. 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

  16. 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

  17. Authors/Acknowledgements • 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: Chris.d@chula.ac.th

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