This study is a 24 week randomized 3 arm multi-center open label trial in Saquinavir (hard capsule) experienced patients. These HIV infected patients will be randomized to receive either a continuation of the hard capsule or arm 2- the new soft gelatin capsule of saquinavir which will replace the SQVhc in their drug regimen or arm 3- indinavir which will replace the Saquinavir hard capsule in their drug regimen. Subjects will continue on their same non-protease anti-HIV drugs, if on any therapy. At 8 weeks, subjects receiving SQVhc will be switched to open label Indinavir for weeks 8-24. Subjects receiving Saquinavir soft gel capsule and subjects receiving Indinavir will continue on their randomized therapy for 24 weeks unless they have no virologic response to their new therapy. Viral RNA levels will be obtained pre, during and post study enrollment.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR005096-10A1
Application #
6122122
Study Section
Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
10
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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