This is a prospective, open-label pharmacokinetic interaction study of the addition of efavirenz to a four-drug antiretroviral regimen containing 2 nucleoside analogs, ritonavir, and saquinavir. 16 HIV-infected, asymptomatic subjects on a stable (two weeks) regimen of any two nucleoside analogs and ritonavir (400 mg BID) and saquinavir (400 mg TID) with Viral RNA below the limits of detection of first generation assays are being studied. Efavirenz, a non-nucleoside transcriptase inhibitor, is added to the patients current regimen followed later by doubling the saquinavir. Three 24 hour PK periods are involved, one for each of the 3 regimens.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-41
Application #
6590571
Study Section
Special Emphasis Panel (ZRR1)
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
41
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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