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Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)

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

Record History

  1. Primary completion date changed from estimate of Dec 2024 to Jul 4, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2025 to Dec 31, 2025
    • Site details revised at 2 of 2 sites
    v7
  2. Site contacts updated at 1 of 2 sitesv6
  3. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 2024
    • Study sites: 0 to 2
    • Study completion date: Dec 31, 2023 to Dec 2025
    • Start date changed from estimate of Apr 30, 2023 to May 24, 2023
  4. Start date: Jan 30, 2023 to Apr 30, 2023v4
  5. Start date: Oct 30, 2022 to Jan 30, 2023v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetectable HIV viral load (VL) (\< 50 copies/mL) and an indication for tuberculosis (TB) preventive treatment (TPT), will be switched to dolutegravir (DTG) with tenofovir/emtricitabine (TDF/FTC), tenofovir/lamivudine (TDF/3TC), abacavir/lamivudine (ABC/3TC) or zidovudine/lamivudine (AZT/3TC) in accordance with South African National HIV Guidelines. Groups 1 and 2 will receive weekly HP for 12 total doses starting 4 weeks after initiating DTG. Individuals who are on an existing DTG-based plus two NRTI antiretroviral therapy (ART) regimen for at least four weeks (and have not received efavirenz, or nevirapine or lopinavir/ritonavir for at least four weeks) who have an undetectable HIV viral load may also participate.
Trial Details
NCT Number NCT05122767
Lead Sponsor The Aurum Institute NPC
Collaborators: Johns Hopkins University
Conditions
(from sponsor)		 Tuberculosis, HIV
Related terms Tuberculosis
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov