Efficacy and Safety of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients

• Status: Terminated
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (PK) interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to HIV patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir.

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

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Bristol-Myers Squibb; Gilead Sciences
• Treatments: Atazanavir Sulfate; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Males and non pregnant females 18 years of age and older who have confirmed laboratory diagnosis of HIV infection and documented failure (plasma HIV RNA level over 10,000 copies/ml) to at least two protease inhibitors (ritonavir [RTV] must have been given at a dose over 400 mg twice a day (bid), in order to qualify for a protease inhibitor in this study) and one non-nucleoside reverse transcriptase inhibitor (NNRTI)

• Ongoing antiretroviral therapy at inclusion without change within the last month

• No threshold of CD4 cell count

• Patients naive of atazanavir and tenofovir DF

Exclusion Criteria:

• Cardiomyopathy

• QTc interval over 450 msec and pause length over 3 seconds on screening EKG

• Heart rate below 40 bpm

• Third degree heart block, and clinical symptoms potentially related to heart block

• Ongoing immunotherapy including IL2, interferon or HIV specific vaccine

• Ongoing opportunistic infection