drugset / Trial / NCT03731559
Efficacy, Safety and Pharmacokinetics of DTG with RIF
Phase 2
Recruiting
200 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute · collabBhumibol Adulyadej Hospital · collabChulalongkorn University · collabInfectious Disease Buddhachinaraj Phitsanulok Hospital · collabInfectious Disease Chiangrai Prachanukroh Hospital · collabInfectious Disease Chonburi Hospital · collabInfectious Disease Taksin Hospital · collabKlang Hospital · collabMinistry of Health, Thailand · collabRadboud University Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV/TB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.
Timeline
- Start
- 2019-06-25
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dolutegravir | Other / unclassified | 50 mg | — |