Paediatric HIVDevelopment

 

  • 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; Family AIDS Care and Education Services (FACES) Project, Kenya; Gertrude’s Children’s Hospital, Kenya; Ifakara Health institute, Tanzania; Joint Clinical Research Centres, 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; Nyumbani Lea Toto Project, Children of God Relief Institute (COGRI), Kenya; St Lumumba Health Centre, Kenya; Swiss Tropical and Public Health Institute, Switzerland; 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.

 

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 LIVING study has been expanded to Uganda and Tanzania. This study tested the use of these pellets in the field in combination with a class of ARVs known as nucleoside reverse transcriptase inhibitors (NRTIs), namely zidovudine/ lamivudine (AZT/3TC) or abacavir/lamivudine (ABC/3TC). The study is intended to demonstrate the effectiveness, safety, and acceptability of LPV/r oral pellets in the field and pave the way for the 4-in-1. This study marks the first time that these pellets are being used in real-life settings and the findings will undoubtedly help programmes worldwide scale up treatment for HIV-infected children.

As of the end of 2017, 818 paediatric patients had been enrolled at 12 sites. Interim results were presented at the end of 2017 at the ICASA conference, showing that oral “2- in-1” pellets are effective, well tolerated, and well accepted by caregivers and children. Based on experience gained from introducing the 2-in-1, DNDi will work with health ministries, donors, and other HIV stakeholders to ensure that children will have access to the 4-in-1 when it is available.

Patients were recruited in Kenya (221 patients out of a target 350) and Uganda (167 patients out of a target 350) for the implementation study. Clinical trials will also be initiated in South Africa, Tanzania, Zambia in 2017.
The LIVING study started in Kenya in September 2015.


Last update: March 2018