drugset / Trial / NCT00196599
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
Phase 2
Completed
39 enrolled
ANRS, Emerging Infectious Diseases
Bristol-Myers Squibb · collabDupont Applied Biosciences · collabGilead Sciences · collabTriangle Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.
Timeline
- Start
- 1999-02
- Primary completion
- —
- Completion
- 2004-09
Publications
- Background Molina JM, Ferchal F, Rancinan C, Raffi F, Rozenbaum W, Sereni D, Morlat P, Journot V, Decazes JM, Chene G. Once-daily combination therapy with emtricitabine, didanosine, and efavirenz in human immunodeficiency virus-infected patients. J Infect Dis. 2000 Aug;182(2):599-602. doi: 10.1086/315711. Epub 2000 Jul 13.
- Background Molina JM, Peytavin G, Perusat S, Lascoux-Combes C, Sereni D, Rozenbaum W, Chene G. Pharmacokinetics of emtricitabine, didanosine and efavirenz administered once-daily for the treatment of HIV-infected adults (pharmacokinetic substudy of the ANRS 091 trial). HIV Med. 2004 Mar;5(2):99-104. doi: 10.1111/j.1468-1293.2004.00194.x.
- Results Molina JM, Journot V, Furco A, Palmer P, De Castro N, Raffi F, Morlat P, May T, Rancinan C, Chene G; Montana (ANRS 091) Study Group. Five-year follow up of once-daily therapy with emtricitabine, didanosine and efavirenz (Montana ANRS 091 trial). Antivir Ther. 2007;12(3):417-22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Didanosine | Small molecule | — | — |
| Subject | Efavirenz | Other / unclassified | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |