Paediatric HIV Translation

 

  • 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 two solid taste-masked first-line LPV/r-based fixed-dose formulations with two NRTIs, 3TC plus ABC or AZT.

 

 

Pharmacokinetic modelling was carried out to determine drug dosages within potential 4-in-1 formulations, and the proposed dosing for the two 4-in-1 LPV/r based FDCs and RTV booster were incorporated into Annex 7 of the WHO’s new Consolidated Guidelines on The Use of Antiretroviral Drugs for Treating and Preventing HIV Infection, under ‘urgently needed ARV drugs for children recommended by the Paediatric ARV Working Group’ in 2013.

New formulations of LPV/r pellets are required to optimize bioavailability and taste-masking, but this has proved to be very challenging.

Following preliminary studies, the best formulation candidates in terms of bioavailability and taste-masking have been chosen for testing in healthy human volunteers in Phase I studies that are ongoing.
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: February 2017