drugset / Trial / NCT02631473
PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage
Timeline
- Start
- 2015-11
- Primary completion
- 2017-11
- Completion
- —
Outcome
Outcome not reported
Stopped (Business): “Study is on hold whilst a grant application for further funding is put together”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 50 mg | — |
| Comparator | Efavirenz | Other / unclassified | 200 mg | — |
| Comparator | Efavirenz | Other / unclassified | 300 mg | — |
| Comparator | Efavirenz | Other / unclassified | 400 mg | — |
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Comparator | Kaletra | Unknown | — | — |
| Comparator | Lopinavir | Other / unclassified | 200 mg | — |
| Comparator | Lopinavir | Other / unclassified | 400 mg | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | — |
| Comparator | Ritonavir | Other / unclassified | 200 mg | — |