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Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

NCT00080119 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1354

Last updated 2019-02-05

Study results available
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Summary

Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB infection in infants born to HIV-infected mothers.

Conditions

  • HIV Infection
  • Tuberculosis
  • Pneumocystis Jiroveci Pneumonia

Interventions

DRUG

Isoniazid (INH)

Antibiotic for the prevention and treatment of TB

DRUG

Trimethoprim/Sulfamethoxazole (TMP/SMX)

Antibiotic for the prevention and treatment of pneumocystis pneumonia (PCP)

DRUG

Isoniazid Placebo (PL)

Isoniazid placebo and TMP/SMX

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Comprehensive International Program of Research on AIDS

    collaborator OTHER

  • Secure the Future Foundation

    collaborator OTHER

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Shabir Madhi, MD · University of Witwatersrand, South Africa

  • George McSherry, MD · UMDNJ - New Jersey Medical School

  • Charles D. Mitchell, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
91 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Botswana
  • South Africa

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 NCT00080119 on ClinicalTrials.gov