A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir

• Status: Withdrawn
• Trial end date: 2014-12-01

Summary

In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen.

This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus > 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.

• Phase: Phase 3

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP); Institut de Recherche pour le Developpement, France; Institute of Tropical Medicine, Belgium; Ludwig-Maximilians - University of Munich; NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania; Swiss National Science Foundation; University of Limpopo
• Treatments: Atazanavir Sulfate; Lopinavir; Ritonavir