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ACTIVE NOT RECRUITING
NCT05122026
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Rifapentine

As included in arm/group description

DRUG

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