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

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.

Conditions

• HIV Infections

Interventions

DRUG

AZT-3TC-LPV/r twice a day

AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily

DRUG

ABC-3TC-EFV once a day

ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Public Research Centre Health, Luxembourg

  collaborator OTHER

• Ministry of Foreign Affairs, Luxembourg

  collaborator UNKNOWN

• University of Ouagadougou, Burkina Faso

  collaborator OTHER

• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

  collaborator OTHER

• Ministry of Health, Rwanda

  collaborator OTHER_GOV

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• University of Bordeaux

  collaborator OTHER

• Institut de Sante Publique, d'Epidémiologie et de Développement

  collaborator UNKNOWN

• Université Montpellier

  collaborator OTHER

• University of Paris 5 - Rene Descartes

  collaborator OTHER

• Queen Fabiola Children's University Hospital

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Marguerite Timite-Konan · Service de pédiatrie - CHU Yopougon - Abidjan, Côte d'Ivoire

• Jules Mugabo · Center for Infectious Desease Control - Kigali, Rwanda

• Nicolas Meda · Université de Ouagadougou - Ouagadougou, Burkina Faso

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• Burkina Faso
• Côte d’Ivoire

Study Locations