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Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

Study acronym: 1 to 3
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Oct 28, 2024 to Jul 11, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Site details revised at 4 of 4 sites
    v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2023 to Jul 19, 2023
    • Study sites: 1 to 4
    v5
  3. Notable Start date: Oct 30, 2022 to Apr 1, 2023v4
  4. Minor Eligibility criteria expanded, about 189 wordsv3
  5. Minor Study sites: 0 to 1v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.
Trial Details
NCT Number NCT05118490
Lead Sponsor The Aurum Institute NPC
Collaborators: Johns Hopkins University
Conditions
(from sponsor)
HIV Seropositivity, Tuberculosis, Household Contact
Related terms HIV Seropositivity, Tuberculosis
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov