CLINICAL TRIAL: HIV TREATMENT-EXPERIENCED PATIENTS TO EVALUATE PA103001-04

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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. This study is a Phase II, randomized, placebo-controlled, double blind, multiple dose, dose-escalation study in HIV treatment experienced patients on a failing antiretroviral regimen, harboring key resistance mutations to at least one member of the anti-HIV medicaition classes. The antiviral activity, safety, and pharmacokinetics of up to five different dose levels of PA103001-04 (Bevirimat) will be compared following multiple oral doses when added to a failing antiretroviral regimen. Initially, a total of 48 patients will be randomized to evaluate the first three dose levels. If the doses are escalated beyond the initial three dose levels, an additional 32 patients may be randomized.