ACTG A5211-SAFETY AND EFFICACY OF SCH 417690 IN HIV-INF, TRTMNT-EXP SUBJCTS

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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. Phase II, randomized, double-blind, multicenter study 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. SCH 417690 is an experimental drug (not approved by the U.S. Food and Drug Administration). It is a member of a new class of drugs, called CCR5 receptor blockers, that block one of the ways HIV enters T cells (the blood cells that fight infection). To enter a T cell, HIV needs to grab onto two parts of the cell (like doors) at the same time. One "door" is called CD4. The other "door" is either CCR5 or CXCR4. Viruses that use the CCR5 "door" are called R5 HIV, and viruses that use the CXCR4 "door" are called X4 HIV. Most people with HIV have R5 HIV. SCH 417690 is made to block the CCR5 "door." SCH 417690 cannot stop X4 HIV from entering the T cell. Subjects will need to be taking other FDA-approved anti-HIV drugs, including ritonavir (Norvir¿, RTV). RTV belongs to a group of drugs called protease inhibitors. RTV and the other anti-HIV drugs will not be supplied by the study. It is a 48 week study (regardless of step) of 120 HIV-infected men and women >18 years old with CD4+ cell count >50 cells/mm3, HIV-1 RNA >5000 copies/mL on a current ritonavir-containing (100-800 mg/day) antiretroviral regimen with R5-only phenotype detected on screening HIV-1 RNA isolate, current regimen stable for the 8 weeks prior to study entry and virologic failure on at least one other 3 or more drug antiretroviral regimen.