Clinical trialNCT00080119TerminatedPhase 2/PHASE3Interventional

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

SponsorInternational Maternal Pediatric Adolescent AIDS Clinical Trials GroupEnrollment1,354HIV InfectionPneumocystis Jiroveci PneumoniaTuberculosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Charles D. Mitchell, MD
University of Miami
Study Chair
clinicaltrials.gov ↗
George McSherry, MD
UMDNJ - New Jersey Medical School
Study Chair
clinicaltrials.gov ↗
Shabir Madhi, MD
University of Witwatersrand, South Africa
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Botswana

Princess Marina Hospital
Gaborone, Botswana

South Africa

University of Cape Town, Red Cross Children'S Hospital
Cape Town, South Africa
University of Stellenbosch, Tygerberg Hospital
Cape Town, South Africa
Nelson R. Mandela School of Medicine, University of Kwazulu Natal, Durban
Durban, South Africa
Chris Hani Baragwanath Hospital, Harriet Shezi Clinic
Johannesburg, South Africa
Perinatal Hiv Research Unit at Chris Hani Baragwanath Hospital
Johannesburg, South Africa

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Isoniazid →Isoniazid PlaceboTrimethoprim →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Feb 2004
Primary completion: 31 May 2009
Completion: 31 May 2009
Last update posted: 5 Feb 2019
Registered enrollment: 1,354
Registry id: NCT00080119

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.