MONOD
ANRS Trial number 12 206

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International phase 2b randomized clinical trial to assess two once-daily simplified antiretroviral triple therapies among HIV infected children treated early by a twice daily triple therapy between 6 and 52 weeks of age and in virological success in Africa
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The main objective is to compare the virological efficiency (proportion of success = follow up of virologic failure) a once daily dose of two simplified triple therapies (monodose) that could allow the protease inhibitors (ABC-3TC-EFV) or not (ABC-3TC-LPV/r), in a phase 2b-3 randomised controlled-trial among HIV-infected children above the age of 15 months old and in virologic success after a 12 months initial phase with a twice daily triple therapy using AZT-3TC-LPV/r.

The expected results for this study, will allow to :

• Study the feasibility (acceptability, tolerance, efficiency) early operational treatment of the HIV infected new born with an initial triple therapy based on the LPV/r in Africa,
• Identify an early, simplified and usable long term retroviral treatment strategy for the HIV infected children, to improve the treatment observation, spare a therapeutic class to the children, and adapt the different contexts in Africa.

Trial is done in Ivory Coast and in Burkina Faso.

Clinical trial registered or www.clinicaltrials.gov: NCT01127204