Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children
Launched by UNIVERSITY OF CAPE TOWN · May 24, 2006
Trial Information
Current as of August 28, 2025
Completed
Keywords
ClinConnect Summary
Tuberculosis (TB) and HIV are dual pandemics occurring in South Africa. Prevention of TB and the subsequent decline in immune function in HIV-infected children is an important strategy to reduce mortality. Isoniazid (INH) prophylaxis reduces TB incidence in HIV-infected adults, but the efficacy in HIV-infected children has not been studied. In 2003, the investigators therefore began a double blind placebo controlled trial to investigate the impact of INH prophylaxis on mortality, morbidity and TB incidence in HIV-infected children. Interim analysis found a striking reduction in mortality an...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • HIV-infected children
- • Resident in Cape Town
- • Informed consent obtainable
- • weight \> 2.5kg
- • Access to transport
- • HAART use for not less than 2 months but not more than 12 months with no significant demonstrated toxicity and good adherence
- Exclusion Criteria:
- • Chronic diarrhoea
- • Current use of INH prophylaxis
- • Prior hypersensitivity to INH prior history of allergy to sulphur drugs
- • Prior history of allergy to sulphur drugs
- • Severe anaemia (haemoglobin less than 7 gm/dl)
- • Neutropenia (absoloute neutrophil count less than 400 cells)
- • Thrombocytopenia (platelet count \< 50 000/uL)
- • Non-reversible renal failure
- • Clinical hepatitis
- • Exposure to household TB contact, requiring INH prophylaxis
About University Of Cape Town
The University of Cape Town (UCT) is a leading research institution in South Africa, renowned for its commitment to advancing medical science and improving public health outcomes. With a strong emphasis on innovation and interdisciplinary collaboration, UCT conducts a wide range of clinical trials aimed at addressing critical health challenges both locally and globally. The university's dedicated research teams leverage cutting-edge methodologies and ethical standards to ensure the integrity and efficacy of their studies, fostering an environment that promotes scientific excellence and enhances the understanding of various medical conditions. Through its robust partnerships with healthcare institutions and community organizations, UCT is poised to make significant contributions to the field of clinical research and the development of effective therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Patients applied
Trial Officials
Heather J Zar, MD PHd
Principal Investigator
University of Cape Town
Mark Cotton, Md PhD
Principal Investigator
University of Stellenbosch
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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