Status:
COMPLETED
Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Medecins Sans Frontieres, Netherlands
Imperial College London
Conditions:
Tuberculosis
Latent Tuberculosis Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
The incidence of Tuberculosis (TB) in poor settlements around Cape Town continues to rise despite highly-active-anti-retroviral therapy (HAART) roll-out and DOTS. In Khayelitsha district, where this p...
Eligibility Criteria
Inclusion
- 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.
- Willingness to participate
- Able to engage in informed consent procedures
Exclusion
- Evidence of active TB or suspicion of active TB as determined by a symptoms screening algorithm.
- Current TB chemotherapy ( TB treatment completed in the preceding 30 days will not be an exclusion)
- Current or previous treatment of latent TB infection since HIV infection (any duration)
- Current treatment with fluoroquinolones or other antibiotics with significant anti-tuberculous activity currently being used to treat TB in South Africa
- Past reaction/intolerance to INH.
- Acute hepatitis or existing Grade III-IV peripheral neuropathy.
- Pregnancy or \< 6weeks post-partum period (Due to increased risk of hepatotoxicity).
- Grade III or higher baseline abnormal liver function. (Note: toxicity grades are all according to ACTG toxicity tables for persons on ART).
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
1368 Patients enrolled
Trial Details
Trial ID
NCT00463086
Start Date
November 1 2007
End Date
November 1 2011
Last Update
July 17 2012
Active Locations (1)
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1
Ubuntu Clinic,Site B Khayelitsha
Cape Town, Western Cape, South Africa