A PHASE I, DOSE-RISING STUDY OF AMD11070 IN HIV-SERONEGATIVE MEN, A5191

这个子项目是众多研究子项目之一

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 were 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 were given AMD11070 with food to determine if this has an affect on the absorption of the drug. A final group took the drug with another HIV medication called 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. Subjects were admitted to the GCRC for drug administration and pharmacokinetic specimen collection, and were monitored closely by clinical (including electrocardiograms or heart tracings) and laboratory evaluations.