PACTG 1020-A: PROTEASE INHIBITOR (BMS 232632) IN COMBINATION REGIMEN IN ART

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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. PACTG 1020-A Version 5.0 is a collaborative study of U.S.A. sites and the PACTG Site in Soweto, South Africa. PACTG 1020-A is designed to provide pharmacokinetic data to guide dosing recommendations for BMS-232632 (ATV, atazanavir, Reyataz ) in infants, children, and adolescents. PACTG 1020-A is the first step on establishing the appropriate dosing for this new protease inhibitor in the pediatric population. BMS-232632 is a novel protease inhibitor (PI), with pharmacokinetic parameters that support once daily dosing, a low pill burden for patients, and convenient powder formulation for younger children. The once daily dosing is a distinct advantage for BMS-232632 in the global fight against HIV infection. Easier to follow antiretroviral regimens may improve adherence in resource-poor settings. This PI is also an attractive agent to bring into the field based on its acceptable safety profile and its lack of effect on cholesterol and triglyceride levels, as evidence in adult studies conducted by BMS. The protocol team believes that it is of high importance, for establishing the right dosing for this PI, to develop preliminary data in other countries (besides the United States of America), where people are infected with non-clade B HIV virus. The PACTG 1020-A Team is aware of the ethical and clinical importance of guaranteeing antiretroviral treatment beyond the data collection phase of the study for South African children participating in the study. Therefore, South African patients will remain on study until BMS-232632 is approved in South Africa and it is available by prescription off-study. At this timepoint, patients will go off-study; however, BMS and the PACTG Soweto Site will continue providing the same antiretroviral treatment (i.e. BMS-232632, ritonavir, and two NRTIs) for as long as they are responding virologically. Additionally, BMS will establish a program with the PACTG Soweto Site to supply alternative antiretroviral treatment if BMS-232632 needs to be discontinued due to virologic failure, toxicity findings, and/or tolerability issues. The sponsor of this study is the U.S.A. Division of AIDS (DAIDS) which holds the IND for this study. Study patients in South Africa will be consented and treated as per South African guidelines. The trial will follow Section 9.0 of The Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants, the principles of the Declaration of Helsinki, (October 2000) and the International Conference of Harmonized Tripartite Guidelines for Good Clinical Practice, (May 1997).