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

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.

Conditions

• HIV

Interventions

DRUG

Lopinavir

Evaluation of second line antiretroviral regimen including boosted lopinavir

DRUG

Atazanavir

Evaluation of second line antiretroviral regimen including boosted atazanavir

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Institut de Recherche pour le Developpement

  collaborator OTHER_GOV

• Swiss National Science Foundation

  collaborator OTHER

• University of Limpopo

  collaborator OTHER

• NIMR-Mbeya Medical Research Program (MMRP)/ Mbeya Referral Hospital, Tanzania

  collaborator UNKNOWN

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Eric Delaporte · Institut de Recherche pour le Developpement

• Issakwisa Mwakyula · NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania

• Mzileni O Mogiyana · University of Limpopo

• Alexandra Calmy · University of Geneva, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2013-05-31

Completion

2014-12-31

Countries

• South Africa
• Tanzania

Study Locations