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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


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:
  • Virological success [ Time Frame: 25 months ] [ Designated as safety issue: No ]
    HIV RNA < 50 copies / mL


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 230
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
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
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 pédiatrie - CHU Yalgado Ouedraogo
Ouagadougou, Burkina Faso
Service de maladies infectieuses - CHU Charles de Gaulle
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

No publications provided

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 16, 2013
Health Authority: Burkina Faso: Ministry of Health
Cote d'Ivoire: Ministry of Health and Public Hygiene
Rwanda: Ethics Committee

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014