Trial | NCT01127204  Report issue

Title

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)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    161
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.
Study Started
Jun 30
2011
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Jul 12
2016
Estimate

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

arm 1 (reference strategy) Active Comparator

AZT-3TC-LPV/r twice a day

arm 2 (simplification strategy) Experimental

ABC-3TC-EFV once a day

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
No Results Posted