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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Notable Results first posted: May 27, 2026v9 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
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Jul 2013 to May 2011
    • Publications: 7 to 10
    v8
  3. Minor Study completion date: Jul 2011 to Jul 2013v7
  4. Notable Primary endpoint revisedv6 Show 8 more changesShow less
    • Primary completion date: Jul 2009
    • Study 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
  5. Minor Enrollment target: 1800 to 2000
    • Study description shortened, about 12 words
    • Eligibility criteria expanded, about 1 word
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study site revised
    v4
  2. Minor Secondary endpoints revised (3)
    • Study title revised
    • Eligibility criteria expanded, about 1 word
    v3
  3. Minor Study site revisedv2
  1. Study First Submitted
  • 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
(from sponsor)
Tuberculosis, HIV Infections
Related terms Acquired Immunodeficiency Syndrome, HIV Infections, Tuberculosis
Enrollment 1,995 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov