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

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: Comprehensive International Program of Research on AIDS; National Institute of Allergy and Infectious Diseases (NIAID); Secure the Future Foundation
• Treatments: Isoniazid; Sulfamethoxazole; Trimethoprim

Criteria

Inclusion Criteria:

• Mother is HIV-infected. Hard copy documentation of the mother's HIV infection is unnecessary if a positive DNA PCR from her infant is available.

• Received Bacille Calmette-Guerin (BCG) vaccine up to and including the 30th day of life and at least 90 days prior to study entry

• Able to complete all study requirements

• Physician assessment of age-appropriate neurodevelopment in which the chronological age is corrected for gestational age for prematurely born infants

• Parent or legal guardian able and willing to provide signed informed consent

• Plan to live in the study area for at least 4 years

• For inclusion in HIV-infected stratum, infant must have a positive HIV-1 DNA PCR; for inclusion in HIV-uninfected stratum, infant must have a negative HIV-1 DNA PCR performed at >= 4 weeks of age

Exclusion Criteria:

• Previous diagnosis of TB infection, TB disease or current treatment for TB infection or TB disease

• Previous receipt of INH

• Contact with a known acid fast bacilli (AFB) sputum smear or culture-positive case of TB before study entry

• Current acute or recurrent (3 or more prior episodes) lower respiratory tract disease

• Chronic persistent diarrhea

• Failure to thrive

• Contraindications for use of INH or TMP/SMX

• Require certain medications

• Known or suspected immune system diseases other than HIV

• Current or previous diagnosis of or treatment for cancer

• Current immunosuppressive therapy greater than 1 mg/kg/day of prednisone or equivalent

• Anticipated long-term oral or intravenous corticosteroid therapy (greater than 3 weeks). Those receiving nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded.

• Grade 3 or greater AST/SGOT, ALT/SGPT, ANC, hemoglobin, platelet count, rash, neuropathy, or myopathy at screening

• Any Grade 4 clinical or laboratory toxicity within 14 days prior to study entry

• Other acute or chronic conditions that, in the opinion of the investigator, may interfere with the study