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

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)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01127204
Enrollment
161
Registered
2010-05-20
Start date
2011-06-30
Completion date
2015-04-30
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Antiretroviral therapy, Infant, Sub Saharian Africa

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.

Interventions

DRUGAZT-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

DRUGABC-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

European and Developing Countries Clinical Trials Partnership (EDCTP)
CollaboratorOTHER_GOV
Public Research Centre Health, Luxembourg
CollaboratorOTHER
Ministry of Foreign Affairs, Luxembourg
CollaboratorUNKNOWN
University of Ouagadougou, Burkina Faso
CollaboratorOTHER
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
CollaboratorOTHER
Ministry of Health, Rwanda
CollaboratorOTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University of Bordeaux
CollaboratorOTHER
Institut de Sante Publique, d'Epidémiologie et de Développement
CollaboratorUNKNOWN
Université Montpellier
CollaboratorOTHER
University of Paris 5 - Rene Descartes
CollaboratorOTHER
Queen Fabiola Children's University Hospital
CollaboratorOTHER
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Initial therapeutic cohort: Virological success12 monthssurvival 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 success25 monthssurvival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25.

Secondary

MeasureTime frameDescription
Virological success12 monthsHIV RNA \< 400 copies / mL
Immunological response12 and 25 monthsCD4+ lymphocyte absolute count and percentage
Adherence12 and 25 monthsmeasurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success
Tolerance12 and 25 monthoccurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome
Antiretroviral and cotrimoxazol pharmacokinetic parameters6, 19 and 25 monthsThe 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.
Resistance to antiretroviral12 and 25 monthsGenotyping to analyse resistance mutation when virological failure

Countries

Burkina Faso, Côte d’Ivoire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026