Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.

The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

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 Sante Publique, d'Epidémiologie et de Développement; Institut National de la Santé Et de la Recherche Médicale, France; Ministry of Foreign Affairs, Luxembourg; Ministry of Health, Rwanda; Programme national,ANRS,Coopération française-Côte d'Ivoire (PAC-CI), Côte d'Ivoire; Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire; Public Research Centre Health, Luxembourg; Queen Fabiola Children's University Hospital; Université Montpellier; University of Bordeaux; University of Ouagadougou, Burkina Faso; University of Paris 5 - Rene Descartes
• Treatments: Lamivudine

Criteria

Inclusion Criteria for antiretroviral treatment initiation:

• infant follow-up in one of the trial site

• HIV-1 infection diagnose by RT PCR after 6 weeks of life

• age between 3 and 12 month at the antiretroviral treatment initiation

• naive of antiretrovirals except if received for the prevention of mother to child HIV transmission

• HB>=7 g/dl, neutrophiles>750/mm3, creatinin<3xULN, TGO and TGP<3xULN

• signed informed consent

Exclusion Criteria for antiretroviral treatment initiation:

• HIV-2 infection or HIV-1/HIV-2 co-infection

• Known intolerance to one of the trial treatment

• HB<7 g/dl, neutrophiles<750/mm3, creatinin>3xULN, TGO or TGP>3xULN

Inclusion Criteria for randomisation at 12 months in the simplification phase:

• age 24 months at most

• virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.

Exclusion Criteria for randomisation at 12 months in the simplification phase:

• virological failure after the first 12 months of antiretroviral treatment