Phase 4
Completed N=1,995
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Source: ClinicalTrials.gov NCT00164281 ↗Enrolled (actual)
1,995
Serious AEs
0.8%
Results posted
May 2026
Primary outcomePrimary: Number of Participants With Incident Tuberculosis — 20; 34 Participants
◆ Published Evidence
Highly cited
357citations · ~24 / year
6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial.
Summary
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.
Linked Publications (5)
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6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial.
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Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana.
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Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana.
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Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy.
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Anti-tuberculosis treatment outcomes in HIV-infected adults exposed to isoniazid preventive therapy in Botswana.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incident Tuberculosis |
20; 34 | — |
| SECONDARY Number of Participants Who Died |
39; 38 | — |
| SECONDARY Tuberculosis and Death Composite Outcome |
59; 72 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-infected
- Age >=18 years
- Tuberculin skin test positive or negative
- Laboratory:
- Hemoglobin (Hgb) >6.5 gm/dl;
- Neutrophil count >1,000 cells/mm3;
- Platelets >75,000/mm3;
- AST (SGOT) =60
- Signed informed consent
Exclusion Criteria
- History of TB in the last 3 years or current active TB
- History of noncompliance to chronic therapies
Data sourced from ClinicalTrials.gov (NCT00164281) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.