Clinical Trial

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

Study acronym: DOLPHIN Moms

Active, Not Recruiting Phase 1/2

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.

Protocol Amendment History 5 amendments

This ClinicalTrials.gov record has been amended 5 times since 2021-11-04; most recent amendment 2025-12-05.

Status change: Recruiting → Active, Not Recruiting 2025-12-05

Status change: Not Yet Recruiting → Recruiting 2024-03-15

Trial Details

NCT Number	NCT05122026
Lead Sponsor	The Aurum Institute NPC Collaborators: Johns Hopkins University, Weill Medical College of Cornell University, University of Washington
Conditions	HIV Seropositivity, Pregnancy, Tuberculosis Infection
Enrollment	252 participants
Start Date	2024-01-17
Primary Completion	2025-10-24 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-12