Paediatric HIVTranslation


  • Target disease: Paediatric HIV
  • Main partners (since project start): Cipla, India; Department of Health, South Africa; Medical Research Council, UK; UNITAID; Centre for Disease Control and Prevention (CDC)/President’s Emergency Plan for AIDS Relief, USA; Médecins Sans Frontières; Necker Institute, France; various academic partners in South Africa and Kenya; AbbVie, USA; WuXi AppTech, China.
  • Project start: 2012
  • Funding (since project start): French Development Agency (AFD), France; Médecins Sans Frontières/Doctors without Borders, International/Norway; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; UNITAID, Switzerland.


Overall Objective:

  • Develop and register a solid taste-masked first‑line LPV/r-based fixed-dose formulation with two NRTIs, 3TC and prioritizing ABC as the second NRTI.



The objective is to combine the four drugs needed for the treatment of paediatric HIV into an easy-to-use single unit, or fixed dose combination, which is heat-stable, taste-masked, solid, does not contain alcohol or inappropriate solvents.


A first-line “4-in-1” fixed-dose combination (abacavir/lamivudine/lopinavir/ritonavir) is on track to be submitted for registration in late 2018. In 2017, pharmacokinetic studies in healthy human volunteers were conducted with a final 4-in-1 formulation. Paediatric studies are planned in Uganda and South Africa.

Following preliminary studies, the best formulation candidates in terms of bioavailability and taste-masking have been chosen – out of the 30 formulations evaluated since 2014 – for testing in healthy human volunteers in on-going Phase I studies.

Three of the most promising formulations tested in previous in vivo studies were assessed, and were found to be highly bioavailable in phase I studies in man. Additional bioavailability studies and standardized electric tongue taste testing (e-tongue) of granules with modified coatings and different polymers will be performed in 2016.

Last update: March 2018