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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

Study acronym: DOLPHIN Moms
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2024 to Oct 24, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 31, 2025 to Dec 31, 2025
    • Site details revised at 3 of 3 sites
    v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date changed from estimate of Jan 30, 2023 to Jan 17, 2024
    • Study sites: 1 to 3
    • Primary completion date: Oct 30, 2024 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Mar 31, 2025
  3. Start date: Oct 30, 2022 to Jan 30, 2023v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study sites: 0 to 1
    • Interventions: Daily rifapentine and isoniazid for 4 weeks (Drug), Weekly rifapentine and isoniazid for 12 weeks (Drug) to Isoniazid (Drug), Rifapentine (Drug)
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 HIV Seropositivity, Pregnancy, Tuberculosis Infection
Related terms HIV Seropositivity, Latent Tuberculosis
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov