Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborator
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 11, 2016
Last Verified: July 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : AZT-3TC-LPV/r twice a day
Drug : ABC-3TC-EFV once a day
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • 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.
  • 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 Outcome Measures:
  • Virological success [ Time Frame: 12 months ]
    HIV RNA < 400 copies / mL
  • Immunological response [ Time Frame: 12 and 25 months ]
    CD4+ lymphocyte absolute count and percentage
  • 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.
  • 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
  • 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
  • Resistance to antiretroviral [ Time Frame: 12 and 25 months ]
    Genotyping to analyse resistance mutation when virological failure

Enrollment: 161
Study Start Date: June 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: arm 1 (reference strategy)
AZT-3TC-LPV/r twice a day
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

Experimental: arm 2 (simplification strategy)
ABC-3TC-EFV once a day
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

Eligibility

Eligibility

Ages Eligible for Study: 3 Months to 12 Months  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127204

Locations

Burkina Faso
Service de maladies infectieuses - CHU Charles de Gaulle
Ouagadougou, Burkina Faso
Service de pédiatrie - CHU Yalgado Ouedraogo
Ouagadougou, Burkina Faso
Côte D'Ivoire
CEPREF
Abidjan, Côte D'Ivoire
FSU abobo-Avocatier
Abidjan, Côte D'Ivoire

Sponsors and Collaborators

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

Investigators

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
More Information

More Information


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   History of Changes  
Other Study ID Numbers: ANRS 12206 MONOD  
  IP.2007.33011.002  
Study First Received: May 19, 2010  
Last Updated: July 11, 2016  

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

HIV
Antiretroviral therapy
Infant
Sub Saharian Africa

Additional relevant MeSH terms:
HIV Infections
Anti-Retroviral Agents
Lamivudine

ClinicalTrials.gov processed this data on August 19, 2019
This information is provided by ClinicalTrials.gov.