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

NCT00122577 | Terminated Phase 2

• 1 other identifier: ANRS 107 Puzzle 2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV Infections

Keywords

HIV infections; Treatment Failure; tenofovir; atazanavir

Outcome Measures

Primary Outcomes (1)

• Change in plasma HIV RNA level and percentage of patients with undetectable HIV-RNA in plasma at Week 26

Secondary Outcomes (7)

• Tolerance during the study

• Changes in CD4+ counts at week 26

• Emergence of drug-resistant viruses

• Rate of virus decay in plasma in group 2 during the initial phase (14 days) of therapy according to baseline EC50 of atazanavir

• Pharmacokinetic (PK) profile of atazanavir alone at day 14

Interventions

Tenofovir DRUG

Atazanavir DRUG

Ritonavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• No threshold of CD4 cell count
• Patients naive of atazanavir and tenofovir DF

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Bristol-Myers Squibb: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Service d'Immunologie clinique Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (2)

• Piketty C, Gerard L, Chazallon C, Calvez V, Clavel F, Taburet AM, Girard PM, Aboulker JP; ANRS 107 Puzzle 2 Study Group. Virological and immunological impact of non-nucleoside reverse transcriptase inhibitor withdrawal in HIV-infected patients with multiple treatment failures. AIDS. 2004 Jul 2;18(10):1469-71. doi: 10.1097/01.aids.0000131340.68666.21.

  PMID: 15199325 RESULT

• Taburet AM, Piketty C, Chazallon C, Vincent I, Gerard L, Calvez V, Clavel F, Aboulker JP, Girard PM. Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother. 2004 Jun;48(6):2091-6. doi: 10.1128/AAC.48.6.2091-2096.2004.

  PMID: 15155205 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Christophe Piketty, MD

  Hopital Européen Georges Pompidou Paris, service d'immunologie clinique

  PRINCIPAL INVESTIGATOR

• Jean Pierre Aboulker, MD

  Inserm SC10

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: March 1, 2002
• Study Completion: July 1, 2004
• Last Updated: July 28, 2005

Record last verified: 2005-07

Locations

FR (1)