Hiv nat promoting clinical research and rational use of antiretroviral agents in thailand
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HIV-NAT: Promoting clinical research and rational use of antiretroviral agents in Thailand. ART access in resource limited settings. AIDS progression and mortality in less-developed countries continues to rise Causes: Access to antiretroviral therapy (ART)

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

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Hiv nat promoting clinical research and rational use of antiretroviral agents in thailand

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


Art access in resource limited settings

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


Hiv nat history

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

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?


Hiv nat trials

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


Hiv nat promoting clinical research and rational use of antiretroviral agents in thailand

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


Hiv nat outcomes 1

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 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

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

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

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


3x5 or agenda 2

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


3x5 or agenda 3

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


Hiv nat summary

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

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

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

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: [email protected]


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