A5211 STUDY OF THE SAFETY AND EFFICACY OF SHC417690 IN HIV-INFECTED SUBJECTS

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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. A5211 is a prospective, open-label, multicenter, 30-week pilot trial (with follow-up continuing to 54 weeks) in HIV-1-infected subjects with virologic suppression for at least 48 weeks on their first protease inhibitor (PI)-based regimen (defined as at least 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus at least 1 PI). Prior use of nonnucleoside reverse transcriptase inhibitors is not allowed. At entry, subjects switch from their current PI(s) to ritonavir-boosted atazanavir (ATV/RTV) for 6 weeks to monitor for adverse effects (Step 1). Subjects whose current PIs include ATV are eligible and will enter the study at Step 1. Subjects with a plasma HIV-1 RNA 50 copies/mL at week 3 and those who experience treatment-limiting adverse effects during the 6-week lead-in are discontinued from the study and are replaced. Otherwise, subjects discontinue their NRTIs at week 6 and remain on a maintenance regimen of ATV/RTV alone for the duration of the study Step 2. The primary purpose of this study is to evaluate the risk of virologic failure in subjects 24 weeks after treatment with ATV/RTV maintenance therapy alone. Virologic failure is defined as 2 consecutive plasma HIV-1 RNA measurements ?200 copies/mL. Subjects with HIV-1 RNA measurements 200 copies/mL must return within 30 days for confirmation of virologic failure, at which point real-time genotyping will be performed if the second viral load is 1000 copies/mL. Decisions about future antiretroviral therapy will be made according to current clinical guidelines and may include resumption of previous combination therapy. All subjects who permanently discontinue study treatment on Step 2, including those who change therapy due to virologic failure, will be followed off treatment/on study.