Tuberculosis Clinical Trial
Official title:
Long Term Study of 2 Isoniazid (INH) Prophylactic Regimens With Concomitant Cotrimoxazole (CTX) in HIV-infected Children - Impact on Morbidity, Mortality, Bacterial Resistance and Incidence of Tuberculosis
Verified date | April 2019 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 infections in HIV-infected children and is currently the recommended standard of care. However, isoniazid has only been studied in HIV-infected adults (in whom it has been shown to substantially reduce the incidence of tuberculosis). In a randomised controlled study of isoniazid in HIV-infected children, the investigators found that INH reduced mortality and tuberculosis incidence in excess of 50%; the data safety monitoring board recommended termination of the placebo arm given the beneficial effects of INH. The investigators therefore aim to follow-up these children to compare the long term impact of two different INH and CTX preventive regimens (daily versus thrice weekly) on morbidity, mortality, adherence and incidence of adverse reactions. The investigators also aim to investigate the efficacy, safety and tolerability of INH compared with placebo for prevention of TB in children receiving HAART as the benefit in this group is unknown.
Status | Completed |
Enrollment | 450 |
Est. completion date | November 15, 2011 |
Est. primary completion date | November 15, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Weeks to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Red Cross Childrens Hospital | Cape Town | Western Cape |
South Africa | Tygerberg Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Medical Research Council, Rockefeller Foundation, University of Stellenbosch |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TB incidence | Jan 2003 to July 2011 | ||
Primary | Mortality | Jan 2003 to July 2011 | ||
Secondary | intercurrent infections | Jan 2003 to July 2011 | ||
Secondary | adherence | Jan 2003 to July 2011 | ||
Secondary | adverse events | Jan 2003 to July 2011 | ||
Secondary | antimicrobial resistance | Jan 2003 to July 2011 |
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