drugset / Trial / NCT05122026
Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV
Phase 1/2
Active not recruiting
252 enrolled
The Aurum Institute NPC
Johns Hopkins University · collabUniversity of Washington · collabWeill Medical College of Cornell University · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, and pharmacokinetics (PK), and potential interactions between dolutegravir (DTG) and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of tuberculosis (TB) preventive therapy (TPT). Adults (age ≥18) who are pregnant with a singleton pregnancy (confirmed by ultrasound) at a gestational age of 20-34 weeks and virally suppressed on an existing DTG-based plus two nucleoside reverse transcriptase inhibitors (NRTI) antiretroviral (ART) regimen for at least four weeks may participate.
Timeline
- Start
- 2024-01-17
- Primary completion
- 2025-10-24
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isoniazid | Small molecule | 300 mg | — |
| Subject | Isoniazid | Small molecule | 900 mg | — |
| Subject | Rifapentine | Small molecule | 600 mg | — |
| Subject | Rifapentine | Small molecule | 900 mg | — |