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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: AZT-3TC-LPV/r twice a day; Drug: ABC-3TC-EFV once a day

• Registration Number: NCT01127204
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Study Start: 2011-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1 (reference strategy)	AZT-3TC-LPV/r twice a day	AZT-3TC-LPV/r twice a day
arm 2 (simplification strategy)	ABC-3TC-EFV once a day	ABC-3TC-EFV once a day

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Virological success	12 months	HIV RNA \< 400 copies / mL
Immunological response	12 and 25 months	CD4+ lymphocyte absolute count and percentage
Antiretroviral and cotrimoxazol pharmacokinetic parameters	6, 19 and 25 months	The following parameters will be measured or calculated: maximal and minimal concentration (Cmax, Cmin), half life (t1/2), Aire Under the Curve (AUC), clearance and volume of distribution, for all antiretroviral (according to treatment arm : AZT, 3TC, LPV, ABC, EFV) and cotimoxazol.
Tolerance	12 and 25 month	occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome
Adherence	12 and 25 months	measurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success
Resistance to antiretroviral	12 and 25 months	Genotyping to analyse resistance mutation when virological failure

Trial Locations

Locations (4)

Service de pédiatrie - CHU Yalgado Ouedraogo; 🇧🇫 Ouagadougou, Burkina Faso

CEPREF; 🇨🇮 Abidjan, Côte D'Ivoire

FSU abobo-Avocatier; 🇨🇮 Abidjan, Côte D'Ivoire

Service de maladies infectieuses - CHU Charles de Gaulle; 🇧🇫 Ouagadougou, Burkina Faso