At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 enrolled
Drug / intervention
Isoniaziddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants
In Brief
A Phase 2 clinical trial evaluating Isoniazid for Tuberculosis. Completed, enrolled 300 participants across 1 site.
Detailed Summary
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesKenya
CollaboratorsThrasher Research Fund
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartAug 2016
Primary CompletionOct 2019
Study CompletionDec 2020
TodayJul 2026
First PostedNov 24, 2015
Enrollment StartAug 1, 2016
Primary CompletionOct 1, 2019
Study CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.6 years ago
Interventions
Isoniaziddrug
HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.