DNDI
The Living study 2018-19 is a multi-country study – across Tanzania, Kenya and Uganda – funded by the Drugs for Neglected Diseases Initiative (DNDI), which aims at evaluating the effectiveness of Lopinavir/ritonavir (LPV/r) pellets, in addition to other NRTIs, in pediatric ART in routine care settings, among children who cannot swallow tablets.
The study addresses a major global challenge of limited options and formulations of antiretroviral drugs for pediatric ART. In Tanzania, the study is implemented by MDH in collaboration with Ifakara Health Institute (IHI) and has three study sites in Dar es Salaam and Morogoro regions. The study employs a single-arm phase IIIB non-randomized, non-comparative, open label study design and evaluates a composite primary endpoint of virologic response, being alive and on study drug at 48 weeks as the primary study endpoint. Other outcomes include treatment adherence, drug resistance, clinical and immunological failure and adverse events. By the end of 2018 all study sites had completed enrollment and were at different stages of follow-up.