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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Public Research Centre Health, Luxembourg
Ministry of Foreign Affairs, Luxembourg
University of Ouagadougou, Burkina Faso
Programme national,ANRS,Coopération française-Côte d'Ivoire (PAC-CI), Côte d'Ivoire
Ministry of Health, Rwanda
Institut National de la Santé Et de la Recherche Médicale, France
University of Bordeaux
Institut de Sante Publique, d'Epidémiologie et de Développement
Université Montpellier
University of Paris 5 - Rene Descartes
Queen Fabiola Children's University Hospital
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01127204
First received: May 19, 2010
Last updated: July 16, 2013
Last verified: July 2013

May 19, 2010
July 16, 2013
June 2011
June 2014   (final data collection date for primary outcome measure)
Virological success [ Time Frame: 25 months ] [ Designated as safety issue: No ]
HIV RNA < 50 copies / mL
Same as current
Complete list of historical versions of study NCT01127204 on ClinicalTrials.gov Archive Site
  • Virological success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HIV RNA < 400 copies / mL
  • Immunological response [ Time Frame: 12 and 25 months ] [ Designated as safety issue: No ]
    CD4+ lymphocyte absolute count and percentage
  • Antiretroviral and cotrimoxazol pharmacokinetic parameters [ Time Frame: 6, 19 and 25 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 25 month ] [ Designated as safety issue: Yes ]
    occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrom
  • Adherence [ Time Frame: 12 and 25 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 and 25 months ] [ Designated as safety issue: Yes ]
    Genotyping to analyse resistance mutation when virological failure
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • Active Comparator: arm 1 (reference strategy)
    AZT-3TC-LPV/r twice a day
    Intervention: Drug: AZT-3TC-LPV/r twice a day
  • Experimental: arm 2 (simplification strategy)
    ABC-3TC-EFV once a day
    Intervention: Drug: ABC-3TC-EFV once a day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
3 Months to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Côte D'Ivoire
 
NCT01127204
ANRS 12206 MONOD, IP.2007.33011.002
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Public Research Centre Health, Luxembourg
  • Ministry of Foreign Affairs, Luxembourg
  • University of Ouagadougou, Burkina Faso
  • Programme national,ANRS,Coopération française-Côte d'Ivoire (PAC-CI), Côte d'Ivoire
  • Ministry of Health, Rwanda
  • Institut National de la Santé Et de la Recherche Médicale, France
  • University of Bordeaux
  • Institut de Sante Publique, d'Epidémiologie et de Développement
  • Université Montpellier
  • University of Paris 5 - Rene Descartes
  • Queen Fabiola Children's University Hospital
Principal Investigator: Marguerite Timite-Konan Service de pédiatrie - CHU Yopougon - Abidjan, Côte d'Ivoire
Principal Investigator: Jules Mugabo Center for Infectious Desease Control - Kigali, Rwanda
Principal Investigator: Nicolas Meda Université de Ouagadougou - Ouagadougou, Burkina Faso
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP