PHASE I B/IIA DOSE-FINDING SAFETY AND ACTIVITY STUDY OF AMD11070 (AN ORALLY

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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 in HIV-infected men and women who may have failed any number of prior antiretroviral regimens or had no prior antiretroviral therapy. Subjects are to be admitted to the general clinical research center (GCRC) for the dosing period; treatment will continue for 10 consecutive days. Thirty-six-hour pharmacokinetic (PK) profiles (intensive 24-hour PK and a trough level at Hour 30-38) will be obtained. Total sample size for this multi-center study is 48 subjects with study duration of 90 days. Subjects will also undergo physical exams, cardiac monitoring, and laboratory safety, virology, and immunology evaluations.