A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Plasma HIV-1 RNA titers \> 10,000 copies/ml.
• • CD4 cell count \> 100 cells/mm3.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with any of the following conditions will be excluded:
• • Any prior anti-retroviral drug therapy.
• Prior Medication:
• Excluded:
• • Previous anti-retroviral drug therapy.