Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda)

NCT01127204 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	ANRS, Emerging Infectious Diseases
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	161
Start date	2011-06
Completion	2015-04

Conditions

• HIV Infections

Interventions

• AZT-3TC-LPV/r twice a day
• ABC-3TC-EFV once a day

Primary outcomes

• Initial therapeutic cohort: Virological success — 12 months
  survival without virological failure (death or loss of follow-up or virologic failure, i.e. HIV-ARN ≥400 copies/mL on one consecutive sample), analysis of resistance profile.
• Randomised simplification phase: Virological success — 25 months
  survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.

Countries

Burkina Faso, Côte d’Ivoire