Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children
Status:
Completed
Trial end date:
2011-11-15
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Cape Town
Collaborators:
Medical Research Council Rockefeller Foundation University of Stellenbosch
Treatments:
Isoniazid Trimethoprim, Sulfamethoxazole Drug Combination