Paediatric HIV Development

 

  • Target disease: Paediatric HIV
  • Main partners (since project start): Joint Clinical Research Centre, Uganda; Baylor College of Medicine Children’s Foundation, Uganda; Epicentre, Uganda; University of Nairobi, Kenya; Gertrude’s Children’s Hospital, Kenya; Kenya Medical Research Institute, Kenya; Associated Medical Sciences/PHPT International Research Unit, Thailand; Department of Health, South Africa; Cipla Ltd., India; UNITAID; St Lumumba Health Centre, Kisumu, Kenya; Mbagathi District Hospital, Kenya; Moi Teaching and Referral Hospital, Kenya; Ministry of Health, Kenya; Clinton Health Access Initiative, USA.
  • Project start: 2014
  • Funding (since project start): French Development Agency (AFD), France; Médecins Sans Frontières/Doctors without Borders, International; UNITAID, Switzerland.

 

Overall Objective:

  • Evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed-dose combination (FDCs) tablet in an implementation study in HIV-infected infants and young children who cannot swallow tablets.

 

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 study was extended to Uganda in 2016. Recruitment of patients is currently ongoing (Kenya: 209 patients out of 350 – Uganda: 156 patients out of 350). Other countries where clinical sites will be initiated include Tanzania, South Africa and Zambia in 2017.
The LIVING study started in Kenya in September 2015.


Last update: February 2017