drugset / Trial / NCT00196612
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
Phase 3
Completed
350 enrolled
ANRS, Emerging Infectious Diseases
Bristol-Myers Squibb · collabDupont Applied Biosciences · collabGilead Sciences · collabTriangle Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
Timeline
- Start
- 2001-04
- Primary completion
- —
- Completion
- 2004-09
Publications
- Results Gallien S, Journot V, Rozenbaum W, Yeni P, Morlat P, Poizot-Martin I, Reynes J, Reliquet V, Leclercq P, Simon F, Chene G, Molina JM; ALIZE (ANRS 099) Study Group. Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28.
- Results Molina JM, Journot V, Morand-Joubert L, Yeni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. doi: 10.1086/428091. Epub 2005 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Didanosine | Small molecule | — | — |
| Subject | Efavirenz | Other / unclassified | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |