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 1 Jun 2021
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 the Kenyan and Ugandan sites.
In February 2018, interim results of the LIVING study were released, showing that 83% of the children 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.
News & publications
- 6 June 2017 – Child-friendly formulation of WHO-recommended HIV treatment now approved by the CDSCO
- Interim results of the LIVING study presented at the ICASA Conference 2017
- 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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