Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability
study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose
Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg
tablets) in HIV infected Children.
The study is intended to support the adoption of the 4-in-1 by healthcare providers and will
provide data that may support its registration in certain countries. The study will be
carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to
swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety,
tolerability and acceptability of the 4-in-1.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Drugs for Neglected Diseases
Collaborators:
AMS-PHPT Research Platform (Program for HIV Prevention and Treatment) Baylor College of Medicine Childrens Foundation, Uganda Epcentre Centre Mbarara Research Centre Institute of Tropical Medicine, Belgium Joint Clinical Research Centre- Kampala UNITAID