A working group convened by the Rockefeller Foundation has published a consensus document on clinical research priorities to assist the expansion of antiretroviral treatment efforts in resource-limited settings. The panel included Dr Peter Mugyenyi of Uganda's Joint Clinical Research Center as well as US and British researchers with considerable experience of conducting antiretroviral and anti-tuberculosis studies in Africa.
The key questions highlighted by the group are listed below. The full text article is available free of charge at
The Lancet's website.
Research questions for when treatment should be started
- Is there a clinical advantage to starting antiretroviral treatment in asymptomatic patients with a CD4+ count above 200?
- Are there cheaper and simpler methods of measuring CD4+ cell count?
- Are there cheaper and simpler methods of measuring viral load?
- Are there laboratory markers other than CD4+ cells and viral load that can successfully guide decisions about when to start antiretroviral treatment?
- In the absence of laboratory data, are clinical criteria sufficient to guide decisions about when to start antiretroviral treatment?
Research questions for monitoring of antiretroviral treatment
- Is laboratory testing for effectiveness and toxic effects necessary every 3-4 months, or is less frequent laboratory testing appropriate?
- What is the minimum laboratory monitoring needed to ensure safety and effectiveness?
- Are there less expensive but equally useful methods to measure immune function and viral burden in monitoring of effectiveness of antiretroviral treatment?
- Would an algorithm using only clinical variables (weight gain, quality of life, decreased frequency and severity of complications) to assess treatment success or failure be adequate?
Research questions for selection of drugs
- Can antiretroviral treatment be safely and effectively prescribed by non-physicians using standard regimens and structured clinical algorithms in resource-poor settings?
- What are the most appropriate first-line regimens for resource-limited settings?
- How should treatment failure be defined?
- When should antiretroviral treatment be stopped or changed?
- Should this decision be based on virological, immunological, or clinical indices?
- Are structured treatment interruptions, pulse therapy, or treat-to-safety strategies safe and effective?
Research questions for adherence to treatment
- What are the main determinants/correlates of adherence in resource-poor settings?
- If there are predictable barriers to adherence in these settings, are they modifiable?
- Is fear of disclosure, stigma, or both a barrier to adherence to antiretroviral treatment?
- What effect will traditional healers and the parallel health-care system have on adherence to antiretroviral treatment?
- What are effective adherence interventions? Do they differ from region to region or could a standard package be developed?
References
Rabkin M et al. Antiretroviral treatment in resource-poor settings: clinical research priorities. The Lancet 360: 1503-05, 2002.