Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether isoniazid can safely (and further) reduce the risk of tuberculosis in HIV infected people receiving HAART.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Collaborators: Imperial College London; Johns Hopkins University; London School of Hygiene and Tropical Medicine; Medecins Sans Frontieres, Netherlands
• Treatments: Isoniazid

Criteria

Inclusion Criteria:

1. Male and female attendees (age ≥18yo) of the Ubuntu HIV and ARV Clinic identified as eligible for the ARV programme will be invited to participate.

2. Willingness to participate

3. Able to engage in informed consent procedures

Exclusion Criteria:

1. Evidence of active TB or suspicion of active TB as determined by a symptoms screening algorithm.

2. Current TB chemotherapy ( TB treatment completed in the preceding 30 days will not be an exclusion)

3. Current or previous treatment of latent TB infection since HIV infection (any duration)

4. Current treatment with fluoroquinolones or other antibiotics with significant anti-tuberculous activity currently being used to treat TB in South Africa

5. Past reaction/intolerance to INH.

6. Acute hepatitis or existing Grade III-IV peripheral neuropathy.

7. Pregnancy or < 6weeks post-partum period (Due to increased risk of hepatotoxicity).

8. Grade III or higher baseline abnormal liver function. (Note: toxicity grades are all according to ACTG toxicity tables for persons on ART).