drugset / Trial / NCT00122577
Efficacy and Safety of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients
Phase 2
Terminated
50 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb · collabGilead Sciences · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-03
- Primary completion
- —
- Completion
- 2004-07
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 300 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | Tenofovir | Small molecule | — | — |