drugset / Trial / NCT00573001
Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)
Phase 3
Completed
120 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences · collabInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.
Timeline
- Start
- 2008-07
- Primary completion
- 2011-07
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir/Ritonavir | Unknown | 100 mg | — |
| Subject | Lopinavir/Ritonavir | Unknown | 400 mg | — |
| Subject | Nevirapine | Small molecule | 200 mg | — |
| Subject | Tenofovir | Small molecule | 300 mg | — |
| Subject | Tenofovir/Emtricitabine | Unknown | 200 mg | — |
| Subject | Tenofovir/Emtricitabine | Unknown | 245 mg | — |
| Comparator | Tenofovir/Emtricitabine/Efavirenz | Unknown | 200 mg | — |
| Comparator | Tenofovir/Emtricitabine/Efavirenz | Unknown | 300 mg | — |
| Comparator | Tenofovir/Emtricitabine/Efavirenz | Unknown | 600 mg | — |
| Subject | Zidovudine | Small molecule | 300 mg | — |