- Target disease: Paediatric HIV
- Main partners (since project start): Associated Medical Sciences/PHPT International Research Unit, Thailand; Baylor College of Medicine Children’s Foundation, Uganda; Cipla Ltd, India; Clinton Health Access Initiative, USA; Department of Health, South Africa; Epicentre, Uganda; FACES Project, Kenya; Gertrude’s Children’s Hospital, Kenya; Joint Clinical Research Centre, Uganda; Kenya Medical Research Institute, Kenya; Kenyatta National Hospital, Kenya; UNITAID; Management and Development for Health (MDH), Tanzania; Mbagathi District Hospital, Kenya; Moi Teaching and Referral Hospital, Kenya; Ministry of Health, Kenya; Swiss Tropical and Public Health Institute, Switzerland; St Lumumba Health Centre, Kisumu, Kenya; University of Nairobi, Kenya.
- Project start: 2014
- Funding (since project start): French Development Agency (AFD), France; Médecins Sans Frontières/Doctors without Borders, International; UNITAID, Switzerland.
Cipla has developed LPV/r pellets in capsules which can be opened and administered orally to small children, allowing the drug to be sprinkled on food and offering the advantage, over the current liquid formulation of these drugs, of being alcohol-free. These pellets do not require a cold chain and are less costly in terms of weight of product for transport; however, their poor taste is still a barrier and they have to be given with two other antiretrovirals which come in dispersible tablet form.
The implementation study (known as the LIVING study) aims to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV/r pellet-based therapies in routine treatment settings in order to facilitate registration, recommendation in national guidelines, and adoption in treatment programmes in the countries concerned.
The LIVING study has been expanded to Uganda and Tanzania, and as of November 2017 has enrolled 750 patients. Results were presented at the end of 2017, showing oral pellets are effective, well tolerated and well accepted by caregivers and children. DNDi will support LIVING study sites and other programmes, as well as national governments, to transition from the interim LPV/r oral pellet to the 4-in-1 when it is available.
Last update: March 2018