ACTG 388: EFZ + NFV W/ 3TC/ZDV &IDV IN HIV+ PTS W/ CD4 <200 &>100,

$21,006M01FY2000RRNIH

New York University School Of Medicine, New York NY

Investigators

Linked publications & trials

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Abstract

This randomized, controlled, open-label study of HIV + subjects with little or no prior antiretroviral treatment and CD4 <200 and > 100,000 HIV RNA copies/ml will compare the additionof efavirenz (EFZ) or nelfinavir (NFV) to a fixed dose of lamivudine/zidovudine (3TC/ZDV) and Indinavir. The primary objectives are to compare time to a virologic failure and evaluate the safety and efficacy of the regimens. Secondary objectives are to evaluate time to virologic response, treatment failure, virologic relapse, biologic phenotypes and resistance, immunologic benefits, and population pharmacokinetics.

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