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Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: May 27, 2026 Primary endpoint revised · Enrollment target: 2000 to 1995 · Secondary endpoints revised (2) · 2 morev9 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 2000 to 1995
    • Secondary endpoints revised (2)
    • Site details revised
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Jul 2013 to May 2011 · Publications: 7 to 10v8 Show 2 more changesShow less
    • Study completion date changed from estimate of Jul 2013 to May 2011
    • Publications: 7 to 10

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  3. Completion date: Jul 2011 to Jul 2013v7
  4. Primary endpoint revised Primary completion date: Jul 2009 · Completion date: Jul 2011 · Interventions: Continued vs. Limited isoniazid preventive therapy (Drug) to Isoniazid (Drug) · 5 morev6 Show 8 more changesShow less
    • Primary completion date: Jul 2009
    • Completion date: Jul 2011
    • Interventions: Continued vs. Limited isoniazid preventive therapy (Drug) to Isoniazid (Drug)
    • Secondary endpoints: 3 to 2
    • Study site revised
    • Publications: 4 to 7
    • Study arms: 0 to 1
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 1800 to 2000 Study description shortened, about 12 words · Eligibility criteria expanded, about 1 wordv5 Show 2 more changesShow less
    • Study description shortened, about 12 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study site revisedv4 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  2. Secondary endpoints revised (3) Study title revised · Eligibility criteria expanded, about 1 wordv3 Show 2 more changesShow less
    • Study title revised
    • Eligibility criteria expanded, about 1 word

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  3. Study site revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. 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.
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
Trial Details
NCT Number NCT00164281
Lead Sponsor Centers for Disease Control and Prevention
Collaborators: Botswana Ministry of Health, United States Agency for International Development (USAID)
Conditions Tuberculosis, HIV Infections
Enrollment 1,995 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov