The primary objective of this study are to assess the safety and efficacy of the combination of two protease inhibitors, Ritonavir and Saquinavir. The safety assessments will include monitoring of adverse events, laboratory abnormalities, and study drug discontinuations throughout the study. Patients who experience a viral rebound while on Ritonavir and Saquinavir therapy will be allowed to add up to two nucleoside analogues to their protease inhibitor regime. Protease gene sequencing and viral isolates characterized with in vitro drug susceptibility testing will be performed both before and at a number of time points after the initiation of nucleoside analogue(s). Patients will be randomized to one of four arms which contains a specific dose and schedule for each study medication. This study enrolled fifteen patients, ten of whom are still participating and are experiencing a significant reduction in their viral activity. Five patients withdrew due to side effects (gastrointestinal symptoms) or inability to maintain compliance with drug regime.

Project Start
1997-01-27
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
34
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Rockefeller University
Department
Type
DUNS #
071037113
City
New York
State
NY
Country
United States
Zip Code
10065
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