This is a randomized, sequential, double blind, placebo controlled, dose ranging study comparing the safety, pharmacokinetics and effects of (+)-calanolide A on surrogate markers when administered to HIV infected people who are naive to antiretroviral therapy and have CD4 cell counts of at least 350 and HIV RNA of at least 10,000. This study is sponsored by Sarawak Medichem Pharmaceuticals and will enroll a total of 32 people at 6 North American sites over 5 months. Up to 10 study patients will be enrolled at BMC. Subjects will be treated for 14 days in two cohorts. Cohort 1 will consist of 16 study participants who will be randomized to receive (+)-calanolide at a dose of 200mg BID or placebo in a ration 3:1. Cohort 1 will be completed and safety results evaluated before cohort 2 randomization and treatment will begin. Cohort 2 will consist of 16 study participants who will be randomized to receive (+)-calanolide at a dose of 400mg BID or placebo in a ratio of 3:1. After review of safety profiles of these doses, additional cohorts may be enrolled and receive higher doses. During the 14 day treatment phase of the study, subjects will have extensive pharmacokinetic sampling as well as serial sampling of routine laboratories, T cell subsets, HIV RNA and HIV genotyping & phenotyping. Study participants will be followed for an additional 14 days after the treatment period with similar clinical evaluation. Three days after the completion of the 14 day treatment period, study participants will be encouraged to start standard therapy with a 3 drug antiretroviral regimen. The study sponsor will provide the antiretroviral therapy for 6 months after completion of the study treatment. (Sarawak Medichem Pharmaceuticals Study Number 57CL-9802)
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