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Completed

NCT Number: NCT01127204

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

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.

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Key information

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZT-3TC-LPV/r twice a day

Drug

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

ABC-3TC-EFV once a day

Drug

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

Primary outcomes

  1. Initial therapeutic cohort: Virological success

    Time frame: 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.

  2. Randomised simplification phase: Virological success

    Time frame: 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 outcomes

  1. Virological success

    Time frame: 12 months

    HIV RNA < 400 copies / mL

  2. Immunological response

    Time frame: 12 and 25 months

    CD4+ lymphocyte absolute count and percentage

  3. Antiretroviral and cotrimoxazol pharmacokinetic parameters

    Time frame: 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.

  4. Tolerance

    Time frame: 12 and 25 month

    occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome

  5. Adherence

    Time frame: 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

  6. Resistance to antiretroviral

    Time frame: 12 and 25 months

    Genotyping to analyse resistance mutation when virological failure

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

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

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 20, 2010
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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