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. The starting dose is based on the results from A5191. Subjects are admitted to the general clinical research center (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. Peripheral blood mononuclear cells will be collected for future analyses of X4 binding and/or receptor expression over time. HIV-1 RNA levels will be assessed on Days 0, 1, 2, 5, 7, 10, 14, 17, 30 and 90. Safety labs will be obtained 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.
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