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Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women

NCT01494038 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 956

Last updated 2021-11-05

Study results available
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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.

Conditions

Interventions

DRUG

Isoniazid (INH)

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)

DRUG

Placebo for isoniazid (INH)

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Amita Gupta, MD, MHS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2017-09-06
Completion
2017-09-06

Countries

  • Botswana
  • Haiti
  • India
  • South Africa
  • Tanzania
  • Thailand
  • Uganda
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494038 on ClinicalTrials.gov