Status:
TERMINATED
Efficacy and Safety of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Bristol-Myers Squibb
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 concomita...
Detailed Description
When licensed, new drugs are widely used in patients failing antiretroviral therapy, including patients with multiple failures. In such patients, having multi-resistant virus, the introduction of one ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00122577
Start Date
March 1 2002
End Date
July 1 2004
Last Update
July 28 2005
Active Locations (1)
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1
Service d'Immunologie clinique Hopital Europeen Georges Pompidou
Paris, France, 75015