Status:
COMPLETED
Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
University of Stellenbosch
Medical Research Council
Conditions:
Tuberculosis
Eligibility:
All Genders
8-15 years
Phase:
PHASE3
Brief Summary
The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections in HIV-infected children and reducing mortality. Cotrimoxazole is well known to reduce mortality and infec...
Detailed Description
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 morta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2011
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00330304
Start Date
January 1 2003
End Date
November 15 2011
Last Update
April 22 2019
Active Locations (2)
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1
Red Cross Childrens Hospital
Cape Town, Western Cape, South Africa, 7700
2
Tygerberg Hospital
Cape Town, Western Cape, South Africa