Phase 4
N=1,995
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Tuberculosis · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00164281 ↗Enrolled (actual)
1,995
Serious AEs
0.8%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Incident Tuberculosis — 20; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isoniazid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Jul 2009
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 | — |
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.
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). 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.