Research Project
7485237
[unreadable] DESCRIPTION (provided by applicant): Botanical compounds are commonly used in the treatment of HIV infection. They are more frequently used as an adjunct to conventional therapy rather than as alternative therapy and are often used together with antiretroviral medications. Drug interactions have been already been encountered with their concurrent use. This research project aims to systematically study the pharmacokinetic and pharmacodynamic interactions between indinavir, a HIV protease inhibitor, and American ginseng (Panax quinquefolius), commonly used by HIV-infected patients. We hypothesize that: 1) ginseng may induce the cytochrome P450 system, decreasing indinavir levels, 2) ginseng will reverse indinavir induced insulin resistance. The research project is designed as a phase I, two-period, multiple dose and single sequence, Iongitudinal pharmacokinetic study in 16 healthy volunteers. Indinavir pharmacokinetic profiles and insulin resistance parameters will be measured without and with concurrent 14 days treatment with American ginseng, which will be subjected to our own independent standardization and quality assurance. We will compare the indinavir area under the curve (AUC), other pharmacokinetic parameters and insulin resistance parameters in the same subjects, with and without concurrent ginseng administration. Further drug interaction and insulin clamp studies are planned. [unreadable] [unreadable]
