Most poor countries with many HIV-infected people, such as those in sub-Saharan Africa, are adopting the WHO ?public health approach? for providing anti-HIV (antiretroviral) drugs. This uses simple approaches to treatment that can be delivered by health care workers under supervision of non-specialist clinicians, supported by basic laboratory tests, available. Doctors in specialist hospitals support clinical teams and problem cases are referred to them for expert management. Without this simplified approach, with the severe shortage of doctors and HIV specialists, scaling up anti-HIV drugs provision to meet the needs of HIV-infected people would be impossible.
However, even simple laboratory tests need significant infrastructure (laboratories, reagents, electricity) and trained personnel. Costs of laboratory tests can be as high as costs of the drugs, and are not feasible in large areas of Africa. Finding out whether or not anti-HIV drugs can be given safely and effectively without the intensive routine laboratory testing provided in industrialised countries is of significant relevance to clinical management of HIV-infected people in the developing world. Many anti-HIV drug treatment programmes are struggling to staff and develop laboratory services - if clinical monitoring only (i.e. with no tests) and laboratory monitoring (with tests) have similar clinical outcomes, then emphasis should be given to support and training for quality clinical services, rather than providing laboratory tests. If HIV disease progresses significantly faster when patients receive anti-HIV drugs without regular tests, then provision of anti-HIV drugs must be accompanied by new resources to strengthen and deliver a basic laboratory service.
This proposal describes an extension to an ongoing clinical trial addressing this and other key issues surrounding management of anti-HIV drugs in resource-limited settings. The reason the trial needs an extension is because disease progression is occurring much less frequently than originally anticipated when the trial was started. This is surprising - but is very good news for anti-HIV programmes in Africa and other resource-limited settings, and for trial participants. However, it also means that longer follow-up is needed to meet the trial?s primary objective of evaluating the relative risks and benefits of giving anti-HIV drugs with and without regular laboratory monitoring tests. Given the potentially huge numbers of HIV-infected people in developing countries, for whom the results of this trial will have a direct impact, we believe it is critical to have longer follow-up of DART patients in order to address these questions as originally planned.