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. AMD11070 is an investigational CXCR4 inhibitor with activity against HIV in vitro. ACTG 5191 is an open-label study to evaluate the safety and pharmacokinetics (drug levels in the blood) of AMD11070. Healthy HIV-negative volunteers will be enrolled and administered single or multiple doses of AMD11070 to determine the maximum dose without significant side effects, and to ascertain the blood levels with each dose. Additional groups will take AMD11070 with food to determine if this has an affect on the absorption of the drug. A final group will take the drug with another HIV medication (Ritonavir) that may affect how the body metabolizes AMD11070. Ritonavir is commonly used in the treatment of HIV and will likely affect the metabolism of AMD11070. Thus, it is important to determine the pharmacokinetics prior to administration of these two drugs concomitantly to HIV infected subjects. Subjects will be monitored closely by clinical (including electrocardiograms or heart tracings) and laboratory evaluations.
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