R&D MODEL & PORTFOLIO
LPV/r pellets with dual NRTI FDC
PROJECT START: 2014 OVERALL OBJECTIVE: Start implementing LPV/r based products
immediately, before the availability of the final, better-adapted 4-in-1 products
• Provide early access to the solid LPV formulation • Gain knowledge on the acceptability of these LPV/r pellets in youngest infants in order to inform the choice of formulations for the ‘4-in-1s’
The implementation study aims to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV/r pelletbased 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 started in Kenya in September 2015 and is planned to expand to Uganda, South Africa, Tanzania, Zimbabwe, and Zambia in 2016.
MAIN PARTNERS: Joint Clinical Research Centre (JCRC), Uganda;
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.
18 paediatric patients recruited at 3 sites
Baylor College of Medicine Children’s Foundation, Uganda; Epicentre, Uganda; University of Nairobi, Kenya; Gertrude’s Children’s Hospital, Kenya; Kenya Medical Research Institute (KEMRI), Kenya; Associated Medical Sciences/PHPT International Research Unit (AMS-PHPT), Thailand; Department of Health, South Africa; Cipla Ltd., India; UNITAID; St Lumumba Health Centre, Kisumu, Kenya; Moi Teaching and Referral Hospital, Kenya; Ministry of Health, Kenya; Clinton Health Access Initiative (CHAI), USA
DNDi Annual Report 2015 › 47