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

Who is this study for? Pregnant people with HIV
What treatments are being studied? Rifapentine+Isoniazid
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• Weight \> 50 kg

• Documented HIV infection

• At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs

• Undetectable HIV-1 viral load

• Pregnancy at 20-34 weeks as confirmed by ultrasound

• Singleton pregnancy

Locations
Other Locations
South Africa
FAMily Centre for Research with Ubuntu (FAMCRU)
RECRUITING
Cape Town
Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital
RECRUITING
Klerksdorp
The Aurum Institute: Tembisa Clinical Research Centre
RECRUITING
Tembisa
Contact Information
Primary
Jayajothi Moodley
JMoodley@auruminstitute.org
+27826593766
Backup
Dr Violet Chihota
vchihota@auruminstitute.org
+27 82 319 1559
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 252
Treatments
Experimental: Arm 1: One month of daily isoniazid and rifapentine (4 weeks)
* DTG 50 mg orally BID~ * DTG 50 mg + 2 NRTI each morning (non-study)~ * 2nd dose: DTG 50 mg each evening (during 1HP)~* 1HP: INH 300 mg + RPT 600 mg each morning for 4 weeks
Experimental: Arm 2: Three months of once-weekly isoniazid and rifapentine (12 weeks)
* DTG 50 mg orally BID~ * DTG 50 mg + 2 NRTI each morning (non-study)~ * 2nd dose: DTG 50 mg each evening (during 3HP)~* 3HP: INH 900 mg + RPT 900 mg each week for 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Weill Medical College of Cornell University, University of Washington, Johns Hopkins University
Leads: The Aurum Institute NPC

This content was sourced from clinicaltrials.gov

Similar Clinical Trials