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This is an investigational fixed-dose combination (FDC) antiretroviral regimen consisting of dolutegravir (DTG), emtricitabine (FTC), and tenofovir alafenamide (TAF). Developed by the PENTA Foundation as part of the UNIVERSAL project, this formulation is specifically designed for pediatric use in children living with HIV, particularly in Sub-Saharan Africa. The regimen combines an integrase strand transfer inhibitor (dolutegravir) with two nucleoside/nucleotide reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide). It is currently being evaluated in the Phase 2 UNIVERSAL1 trial to determine the safety and pharmacokinetics of a novel dose ratio delivered via a dispersible tablet, aiming to bridge the treatment gap for infants and children as small as 3 kg.
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