Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Bristol-Myers Squibb; GlaxoSmithKline; Hoffmann-La Roche
• Treatments: Atazanavir Sulfate; Fosamprenavir; HIV Protease Inhibitors; Protease Inhibitors; Ritonavir; Saquinavir

Criteria

Inclusion Criteria:

• Protease inhibitor naive patients

• Wild type genotype

• CD4 greater than 200/mm3

• Viral load between 10,000 copies/ml and 750,000 copies/ml

• Signed informed consent

Exclusion Criteria:

• Pregnancy; breast feeding

• Antiretroviral (ARV) pretreated patients

• Hyperlipidemic treatment

• Evolutive disease