AMD11070 IN HIV-POSITIVE SUBJECTS (A5210)

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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. A5210 is a dose escalating, open-label, safety and activity study of AMD11070. Subjects are admitted to the GCRC for the dosing period. Treatment will continue for 10 consecutive days. Subjects will be allowed daytime passes away from the GCRC on days 4,6,7,8, and 9. Thirty-six-hour pharmacokinetic (PK) profiles (intensive 24-hour PK and a trough level at Hour 30-38) will be obtained at steady state, beginning with the last dose of AMD11070, and will include terminal PK elimination profiles. Trough PK collections will be drawn on day 6 or 7, depending on the treatment group, to assess CXCR4 receptor saturation and characterize drug accumulation. HIV-1 RNA levels will be assessed on Days 0, 1, 2, 5, 7, 10, 14, 17, 30 and 90. Safety labs will bevobtained at Days 0, 5, 10, 17, 30, and 90. Subjects who have not restarted antiretroviral medications will also be assessed for safety and efficacy on Day 21. Primary Objectives: 1. To determine the safety of several dose levels of AMD11070 (with the starting dose determined by the results of A5191) administered over 10 days to HIV-infected subjects who harbor X4-tropic virus. 2. To determine the proportion of subjects per cohort who have a >1 log10 rlu reduction in X4-tropic virus during 10 days of AMD11070 treatment or in the 7 days following treatment discontinuation, and to describe changes from baseline to Day 10 in log10 rlu corresponding to X4-tropic virus.