Abstract

Many factors may alter pharmacokinetics, including cytochrome P450 phenotype, malnutrition, intestinal parasites, drug source (manufacturer), and drug storage conditions. In this study, in vitro assays of drug bioavailability will be performed using antiretroviral agents produced in several different countries. Pharmacokinetic profiles of several standard regimens will be assessed in several distinct geographic regions. If profiles are substantially different, studies will be performed to assess the cause, and whether dosage regimens different from those recommended in the US might be appropriate to maximize efficacy and safety.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL001170-01
Application #
6546494
Study Section
(CCMD)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code

  Publications

Penzak, S R; Kabuye, G; Mugyenyi, P et al. (2007) Cytochrome P450 2B6 (CYP2B6) G516T influences nevirapine plasma concentrations in HIV-infected patients in Uganda. HIV Med 8:86-91
Penzak, Scott R; Acosta, Edward P; Turner, Michele et al. (2004) Antiretroviral drug content in products from developing countries. Clin Infect Dis 38:1317-9
Penzak, Scott R; Acosta, Edward P; Turner, Michele et al. (2003) Analysis of generic nevirapine products in developing countries. JAMA 289:2648-9