CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 956 enrolled
Drug / intervention
Isoniazid (INH) +1 moredrug
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.

Search/NCT01494038
NCT01494038Phase 4Completed
CompareCT.gov

A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High Tuberculosis (TB) Incidence Settings

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 16, 2011·Updated Nov 5, 2021

In Brief

A Phase 4 clinical trial evaluating Isoniazid (INH) and Placebo for isoniazid (INH) for HIV Infections and Tuberculosis. Completed, enrolled 956 participants across 13 sites in 8 countries.

Detailed Summary

Tuberculosis (TB) is a leading cause of death among HIV-infected persons in low-income settings and can be a serious complication for HIV-infected pregnant women and their infants. Isoniazid (INH) preventive therapy (IPT) is effective in preventing TB infection in HIV-infected adults, but the safety of IPT in pregnant women is unknown. This study evaluated the safety of IPT among HIV-infected pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Tuberculosis
CountriesBotswana, Haiti, India, South Africa, Tanzania, Thailand, Uganda, Zimbabwe
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2011
Enrollment StartAug 19, 2014
Primary CompletionSep 6, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 14.5 years ago

Interventions

Isoniazid (INH)drug

300-mg tablet once daily by mouth, either from entry through Week 28 antepartum (Arm A) or from Week 12 postpartum through Week 40 postpartum (Arm B)

Placebo for isoniazid (INH)drug

Placebo tablet once daily by mouth, either from Week 28 visit through Week 40 postpartum (Arm A) or from entry until Week 12 postpartum visit (Arm B)