Develop and register a solid, taste-masked, first line lopinavir/ritonavir-based fixed-dose formulation with two nucleoside reverse transcriptase inhibitors (NRTIs), lamivudine and abacavir
current phase of drug development
updated 1 Jun 2021
The objective of the 4-in-1 is to combine the four drugs needed for the treatment of paediatric HIV into a single, easy-to-use granule-filled capsule, also called a fixed-dose combination, which is heat-stable, taste-masked, solid, and does not contain alcohol or inappropriate solvents.
The ‘4-in-1’ fixed-dose combination combines the protease inhibitors lopinavir and ritonavir with the nucleoside reverse transcriptase inhibitors (NRTIs) lamivudine and abacavir.
Developed for infants and young children weighing from 3 to 25kg, parents and caregivers will be able to administer the drugs by opening the capsules and sprinkling the granules on soft food, water, or milk. The 4-in-1 does not require refrigeration and is a significant improvement over the current option, a bitter-tasting syrup of lopinavir and ritonavir with high alcohol content that must be refrigerated. Full US Federal Drug Administration (FDA) approval of the 4-in-1 capsule is expected in 2021.
News & press releases
- 29 November 2019 – HIV treatment for children to be produced for under one dollar a day
- 4 June 2019 – Study for a child-friendly HIV treatment begins in Uganda
- 20 July 2012 – DNDi and Cipla to develop 4-in-1 paediatric antiretroviral drug combination – New formulation to fill the deadly gap in appropriate HIV medicines
- 11 December 2012 – Grant from UNITAID awarded to bolster development and delivery of child-adapted antiretroviral (ARV) formulation
- DNDi‘s Partnership of the Year 2013
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