ANRS 12206‐ MONOD.

Trial name or title	ANRS 12206 – MONOD: International phase 2b‐3 randomised clinical trial to assess two once‐daily simplified antiretroviral triple therapies among HIV‐infected children early treated by a 12‐month twice daily triple therapy between 6 weeks and 24 months of age and in virological success in Africa: the MONOD Project (Burkina Faso, Ivory Coast, Rwanda)
Methods	Open label randomised clinical trial
Participants	Inclusion Criteria for antiretroviral treatment initiation: ‐ infant follow‐up in one of the trial sites ‐ HIV‐1 infection diagnosed by RT PCR after 6 weeks of life ‐ age between 3 and 12 month at antiretroviral treatment initiation ‐ antiretroviral‐naive except if received for the prevention of mother to child HIV transmission ‐ HB>=7 g/dl, neutrophils>750/mm3, creatinine<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 treatments ‐ HB<7 g/dl, neutrophils<750/mm3, creatinine>3xULN, TGO or TGP>3xULN Inclusion Criteria for randomisation at 12 months in the simplification phase: ‐ age 24 months at most ‐ virological success, defined as 2 consecutive undetectable 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
Interventions	Drug: AZT‐3TC‐LPV/r twice a day Drug: ABC‐3TC‐EFV once a day Drug: ABC‐3TC‐LPV/r once a day
Outcomes	Primary Outcome Measures: ‐ Virological success at 25 months (HIV RNA < 50 copies / mL) Secondary Outcome Measures: ‐ Virological success at 12 months (HIV RNA < 400 copies / mL) ‐ Immunological response at 12 and 25 months (CD4+ lymphocyte absolute count and percentage) ‐ Antiretroviral and cotrimoxazole pharmacokinetic parameters at 6, 19 and 25 months. ‐ Tolerance at 12 and 25 month (occurrence of grade 3 and 4 adverse events related to the trial treatment, particularly occurrence of immune reconstitution inflammatory syndrome) ‐ Adherence at 12 and 25 months ‐ Resistance to antiretroviral at 12 and 25 months
Starting date	June 2011
Contact information	Dr. Valeriane Leroy Valeriane.leroy@isped.u‐bordeaux2.fr
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