At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,995 enrolled
Drug / intervention
Isoniaziddrug
Likely dose
Isoniazid 300 mg orally daily supplemented with pyridoxine 25 mg for 6 or 36 monthsAI-extracted
Key inclusion· 4
- ✓HIV-infected
- ✓Age 18 years or older
- ✓Karnofsky performance status of 60 or greater
- ✓Tuberculin skin test positive or negative (both acceptable)
Key exclusion· 2
- ✕History of tuberculosis in the last 3 years or current active TB
- ✕History of noncompliance to chronic therapies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
In Brief
A Phase 4 clinical trial evaluating Isoniazid for Tuberculosis and HIV Infections. Completed, enrolled 1,995 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV Infections
CountriesBotswana
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
First PostedSep 2005
Primary CompletionJul 2009
Study CompletionMay 2011
TodayJul 2026
First PostedSep 14, 2005
Enrollment StartNov 1, 2004
Primary CompletionJul 1, 2009
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago
Interventions
Isoniaziddrug
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.