A5211: AN ORALLY ADMINISTERED HIV-1 ENTRY INHIBITOR IN HIV TX EXPERIENCED PTS

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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 is a phase II, double-blind, randomized clinical trial of three doses of SCH 417690 vs. matching placebo with three phases: (1) 42-day screening phase; (2) 14-day double-blind, randomized, placebo-controlled, add-on phase to assess the antiretroviral activity of SCH 417690; and (3) 46-week continuation phase to assess the longer-term safety and tolerability of SCH 417690. During the screening phase a blood sample will be sent for analysis of HIV co-receptor tropism and genotypic and phenotypic testing to assess drug resistance. One hundred twenty HIV-infected men and women greater than or equal to 18 years of age; CD4+ cell count greater than or equal to 50 cells/mm3; R5-only phenotype detected on screening HIV-1 RNA isolate; HIV-1 RNA greater than or equal to 5000 copies/ml on a current ritonavir-containing (total dose 100-800 mg/day) antiretroviral regimen; current regimen stable for the 8 weeks prior to study entry and virologic failure on at least one 3 or more drug antiretroviral regimen will be enrolled. The primary efficacy endpoint is the change in log10 HIV-1RNA from baseline to day 14. Secondary endpoints include safety and tolerability, virologic and immunologic outcomes, clinical outcomes, pharmacokinetic outcomes, viral co-receptor phenotype and adherence