drugset / Trial / NCT05630872
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
Phase 2
Completed
30 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Mylan · collabViiV Healthcare · collab
NaSingle-groupOpen-labelTreatment
Summary
A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).
Timeline
- Start
- 2024-02-13
- Primary completion
- 2025-05-07
- Completion
- 2025-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 50 mg | Oral |
| Background | Isoniazid | Small molecule | 300 mg | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Moxifloxacin | Small molecule | 400 mg | — |
| Background | Pyrazinamide | Small molecule | — | — |
| Background | Rifapentine | Small molecule | 1200 mg | — |
| Background | TDF | Unknown | — | — |