This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator.
SPECIFIC AIMS Primary Objective To demonstrate the non-inferiority of a once-daily PI- and a once-daily NNRTI-containing regimen as compared with standard twice-daily ARV therapy for the initial treatment of individuals infected with HIV-1 from diverse areas of the world. Secondary Objectives To determine the safety of combinations of ARV therapy for the treatment of HIV-1 infection in resource-limited settings and to characterize drug-associated toxicities observed in different geographic and cultural settings. To characterize and compare the patterns and rates of ARV drug resistance during ARV therapy in diverse areas of the world. To examine the effects of ARV therapy on quality of life in diverse areas of the world. To characterize and compare the occurrence and outcomes of opportunistic infections, viral co-infections, and immune reconstitution syndromes, observed during ARV treatment in different geographic settings. To examine associations between nutritional deficiencies and responses to ARV therapy. To investigate efficacy of sequential ARV regimens after failure of primary regimens in diverse areas of the world. To evaluate the effects of concomitant medications, traditional treatments, ethnicity, race, and measures of adherence on plasma ARV concentrations in individuals from diverse areas of the world. Programmatic Objectives Sustained, widespread application of ARV therapy in the areas of the world that are most affected by the AIDS epidemic will require both care providers who are appropriately trained in the use of ARV drugs and methods to measure treatment response that are applicable for resource-limited settings. A5175 will assist in the development of centers of HIV-1 treatment expertise by addressing the following programmatic objectives. To assist with the transfer of immunologic, pharmacologic, and virologic technology and expertise relevant to the conduct of clinical studies of HIV-1 treatment in resource-limited settings. To establish local specimen repositories for future evaluation of the usefulness of simplified measures of virologic and immunologic efficacy and ARV drug resistance in resource-limited settings.
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