Evaluate the effectiveness of lopinavir/ritonavir pellets, given with two NRTIs (either zidovudine plus lamivudine or abacavir plus lamivudine), in an implementation study in infants and young children living with HIV who cannot swallow pills
current phase of drug development
updated 21 Feb 2023
In 2015, following the tentative approval by the US Federal Drug Administration of the lopinavir/ritonavir 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 lopinavir/ritonavir formulation for young children.
The study was expanded to Uganda in 2016 and Tanzania in 2017. By December 2018, the LIVING study had enrolled 1,003 children across 12 sites in Kenya, Uganda, and Tanzania, and follow-up was completed for all sites in April 2019.
Development of the clinical study reports for the LIVING study conducted in Kenya, Uganda, and Tanzania continued throughout 2022. They are expected to be completed in 2023.
Final analyses of results from the LIVING study were completed in late 2021, and findings will be presented at the 29th Conference on Retroviruses and Opportunistic Infection 2022 (CROI 2022). In this study, 990/1003 children received the 2-in-1 LPV/r pellets. Treatment effectiveness at week 48 (primary endpoint) was achieved in 683/990 (69%) children. The proportion of evaluable children with viral load <1,000 copies/ml increased from 53% at baseline to 80% at week 48, and further increased to 89% at week 96. No unexpected safety signals were observed. At the last assessment, 93% of caregivers described the pellets as easy or very easy to administer and 94% reported their children accepted the pellets well.
DNDi is now actively preparing to facilitate access and transition to new child-friendly treatment options, including paediatric dolutegravir-based regimens and the ‘4-in-1’ fixed-dose combination of abacavir, lamivudine, lopinavir, and ritonavir, once it is registered.
DNDi completed the LIVING study in Kenya, Uganda, and Tanzania, after enrolling over 1,000 children across 12 sites in Kenya, Uganda, and Tanzania.
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.
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.
News & resources
- 1 December 2019 - Innovating for kids with HIV
- 1 November 2019 - Ending the Neglect of Paediatric HIV
- 23 July 2019 - Improving care for kids with HIV – Ann’s Story
- 6 June 2017 - Child-friendly formulation of WHO-recommended HIV treatment now approved by the CDSCO
- 3 June 2015 - Child-friendly formulation of WHO-recommended treatment now approved by the US FDA for children living with HIV
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