A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Saquinavir

Criteria

Inclusion Criteria

Patients must have:

• CD4 count of 100 to 500 cells/mm3.

• Greater than 20,000 HIV-RNA copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

Prior treatment with protease inhibitors.

Required:

• Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).

• At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).