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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
Sponsor: The Aurum Institute NPC
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2024-01-17
Completion Date
2025-12-31
Last Updated
2025-12-12
Healthy Volunteers
No
Interventions
Rifapentine
As included in arm/group description
Isoniazid
As included in arm/group description
Locations (3)
FAMily Centre for Research with Ubuntu (FAMCRU)
Cape Town, Cape Town, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, Gauteng, South Africa
Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital
Klerksdorp, North West, South Africa