Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children

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.

Conditions

• Tuberculosis

Interventions

DRUG

Isoniazid

isoniazid 10mg/kg orally, daily, for study period

DRUG

Cotrimoxazole

Cotrimoxazole given 3 times a week or daily, orally, for study period

DRUG

isoniazid

Isoniazid, 10mg/kg daily for study period

OTHER

placebo

Placebo tablet identicle in appearance to intervention: isoniazid table

Sponsors & Collaborators

• University of Stellenbosch

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• Rockefeller Foundation

  collaborator OTHER

• University of Cape Town

  lead OTHER

Principal Investigators

• Heather J Zar, MD PHd · University of Cape Town

• Mark Cotton, Md PhD · University of Stellenbosch

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

8 Weeks

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-01-31

Primary Completion

2011-11-15

Completion

2011-11-15

Countries

• South Africa

Study Locations