Paediatric HIVImplementation

 

  • 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, given with two NRTIs (either AZT/3TC or ABC/3TC), in an implementation study in HIV-infected infants and young children who cannot swallow pills

 

 

In 2015, following the tentative approval by the US FDA of the lopinavir/ritonavir (LPV/r) 2-in-1 pellets developed by Cipla Ltd. (India), DNDi launched the LIVING study in five sites in Kenya to provide early access to the new formulation. The pellets are taken orally and are a significant improvement over the high-alcohol, bitter-tasting and refrigerated syrups that were previously the only available LPV/r formulation for young children. The study was expanded to Uganda in 2016 and Tanzania in 2017.

 

As of December 2018, the LIVING study had enrolled 1,003 children across 12 sites in Kenya, Uganda, and Tanzania, and follow-up was completed for the Kenyan and Ugandan sites.

In February 2018, interim results of the LIVING study were released, showing that 83% of the children in the study were virologically suppressed at 48 weeks with the 2-in-1, compared to 55% at the beginning of the study. These results show that the 2-in-1 is effective and well-tolerated by children.

DNDi is now actively preparing to build on the work on the 2-in-1 to facilitate transition and support access to the 4-in-1, once it is registered.

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: August 2019