Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Gilead Sciences; Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba; Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Nevirapine; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• age over 18 years for Senegal and over 21 years for Cameroon

• HIV-1 infected patient

• patient naive from any antiretroviral treatment

• CD4 cell count over 50 cells per mm3

• contraceptive method use

• informed consent signed

Exclusion Criteria:

• opportunistic infection ongoing or any other serious pathology

• ongoing treatment with rifampicine

• severe renal or hepatic impairment

• HbSAg positive

• Hemoglobine under 8g/L

• Neutrophils under 500 cells per mm3

• ongoing pregnancy or breastfeeding

• treatment by contra-indicated drugs (as described in study drugs notices)