"The Once A Day Protease Inhibitor Regimens"

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing fAPV/r, in ARV-naïve patients over a 96-week period.

This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3. Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd) and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Atazanavir Sulfate; Emtricitabine; Fosamprenavir; HIV Protease Inhibitors; Protease Inhibitors; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• 18 years of age or older.

• Patient agrees to participate in the study by giving written informed consent.

• Documentation of HIV infection.

• No prior treatment with any anti-retroviral agent.

• CD4 cell count < 350 cells x mm3 or with an AIDS defining condition.

• Viral load > 1,000 copies/mL

Exclusion Criteria:

• Less than 18 years old.

• Current pregnancy or breastfeeding.

• Any previous antiretroviral regimen.

• Severe hepatic impairment that precludes the use of either study drug. This will be defined as any laboratory value of Grade 3 or 4 on the ACTG scale.

• Use of any contra-indicated medication as defined in the package insert for each drug.

• Any condition that, in the judgment of the investigator, precludes successful participation in the study.