Status:
TERMINATED
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program of Research on AIDS
Conditions:
HIV Infection
Tuberculosis
Eligibility:
All Genders
91-120 years
Phase:
PHASE2
PHASE3
Brief 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 transm...
Detailed Description
Tuberculosis (TB) and the Human Immunodeficiency Virus (HIV) are major public health problems in southern Africa, and the incidence of TB in South Africa is among the highest in the world. TB is cause...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1354 Patients enrolled
Trial Details
Trial ID
NCT00080119
Start Date
February 1 2004
End Date
May 1 2009
Last Update
February 5 2019
Active Locations (6)
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1
Princess Marina Hospital
Gaborone, Botswana
2
University of Cape Town, Red Cross Children's Hospital
Cape Town, South Africa
3
University of Stellenbosch, Tygerberg Hospital
Cape Town, South Africa
4
Nelson R. Mandela School of Medicine, University of KwaZulu Natal, Durban
Durban, South Africa, 4001