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

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3; Phase 2

Conditions: HIV Infections

Treatments: Drug: AZT-3TC-LPV/r twice a day; Drug: ABC-3TC-EFV once a day

Study type: Interventional

Funder types: Other

Identifiers

NCT01127204

IP.2007.33011.002 (Other Grant/Funding Number)

ANRS 12206 MONOD

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

arm 1 (reference strategy)

Active Comparator group

Description:

AZT-3TC-LPV/r twice a day

Treatment:

Drug: AZT-3TC-LPV/r twice a day

arm 2 (simplification strategy)

Experimental group

Description:

ABC-3TC-EFV once a day

Treatment:

Drug: ABC-3TC-EFV once a day