drugset / Trial / NCT03836833
Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation
Phase 1/2
Unknown
50 enrolled
Drugs for Neglected Diseases
AMS-PHPT Research Platform (Program for HIV Prevention and Treatment) · collabBaylor College of Medicine Children's Foundation · collabEpcentre Centre Mbarara Research Centre · collabInstitute of Tropical Medicine, Belgium · collabJoint Clinical Research Centre- Kampala · collabUNITAID · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2019-06-04
- Primary completion
- 2019-11
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 30 mg | — |
| Subject | Abacavir | Other / unclassified | 60 mg | — |
| Subject | Lamivudine | Other / unclassified | 15 mg | — |
| Subject | Lamivudine | Other / unclassified | 30 mg | — |
| Subject | Lopinavir | Other / unclassified | 40 mg | — |
| Background | Ritonavir | Other / unclassified | 10 mg | — |