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Background: A consensus conference was held to discuss priorities for antiretroviral therapy (ART) research in Zambia, one of the world's most heavily HIV-afflicted nations. Zambia, like other resource-limited settings, has increasing access to highly active antiretroviral therapy (HAART) because of declining drug costs, use of government-purchased generic medications, and increased global donations. For sustained delivery of care with HAART in a resource-constrained medical and public health context, operational research is required and clinical trials are desirable. The priority areas for research are most relevant today given the increasing availability of HAART. Methods: A conference was held in Lusaka, Zambia, in January 2002 to discuss priority areas for ART research in Zambia, with participants drawn from a broad cross section of Zambian society. State-of-the-art reviews and 6 intensive small group discussions helped to formulate a suggested research agenda. Results: Conference participants believed that the most urgent research priorities were to assess how therapeutic resources could be applied for the greatest overall benefit and to minimize the impact of nonadherence and viral resistance. Identified research priorities were as follows: To determine when to initiate HAART in relation to CD4+ cell count To assess whether HIV/AIDS can be managed well without the use of costly frequent viral load measurements and CD4+ cell count monitoring To assess whether HIV/AIDS can be managed in the same fashion in patients coinfected with opportunistic infections such as tuberculosis and HIV-related chronic diarrhea, taking into consideration complications that may occur in tuberculosis such as immune reconstitution syndrome and medication malabsorption in the presence of diarrhea To carefully assess and characterize toxicities, adverse effects, and viral resistance patterns in Zambia, including studies of mothers exposed to prepartum single-dose nevirapine To conduct operational research to assess clinical and field-based strategies to maximize adherence for better outcomes of ART in Zambia To assess ART approaches most valuable for pediatric and adolescent patients in Zambia Conference participants recommended that HIV-related clinical care and research be integrated within home-based care services and operated within the existing health delivery structures to ensure sustainability, reduce costs, and strengthen the structures. Conclusion: Our consensus was that antiretroviral clinical trials and operational research are essential for Zambia to address the new challenges arising from increasing ART availability. There is global consensus that antiretroviral clinical trials in resource-constrained countries are possible, and the capacity for such trials should be developed further in Africa.
Zulu et al. (Thu,) studied this question.