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Standard of Care Issues in Research on HIV

Standard of Care Issues in Research on HIV. Charlie Gilks Surveillance, Research Monitoring and Evaluation Department of HIV/AIDS. Some background comments. General concern with human subject research, increasing over the last two or three decades Some concern with research sponsored by the

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Standard of Care Issues in Research on HIV

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  1. Standard of Care Issues in Research on HIV Charlie Gilks Surveillance, Research Monitoring and Evaluation Department of HIV/AIDS

  2. Some background comments General concern with human subject research, increasing over the last two or three decades Some concern with research sponsored by the rich North, undertaken in the poor South • potential for exploitation • concern about dual standards

  3. Different Worlds … Classically “tropical diseases” in the poor tropics “Transitional” diseases in rich temperate climes Then came HIV to shatter the comfortable dichotomy For the first time a serious and visible disease was a top public health problem in both Manhattan and Malawi Differential responses became increasingly obvious

  4. With HIV research, mounting concerns • HIV research around prevention started to expose serious problems and issues • the use of placebo - as no intervention was standard • the level of care made available in the trial • This then extended into treatment trials • the standard of care in the trial • cessation of active interventions

  5. An entrenchment of views • In the US once chronic/lifelong ARV care was started, it was not usually stopped for any other reason except failure or toxicity • Somehow codification of this standard of care into an ethical absolute that trials could only be done with a commitment to lifelong therapy • It became problematic for Industry and Agencies to fund HIV research in resource-poor settings

  6. Some Consequences • Therapeutic research became blocked, despite the number of questions that existed (we only know how to use ARVs in the North) • Whilst aiming to increase access, operational / translational research was also blocked (learning by doing through scaling up) • This situation was not supportable …...

  7. Responses and progress • Some groups have refused to accept this block on research, because progress cannot be made • Creative responses have emerged - Some trials have started up - Unfortunately others remain blocked • Theme 3 reviews how these issues have been addressed or still are outstanding

  8. Looking forward • What use should be made of these different interpretations and approaches to the standard of care issue to advance/unlock other research on treatment and prevention • A critical theme for WHO as we try to build up the strategic information needs for scaling up ARV programmes - impossible without research

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