A study to compare early vs delayed treatment for HIV in patients with HIV and tuberculosis
Not Applicable
Completed
- Conditions
- Health Condition 1: null- HIV & TB
- Registration Number
- CTRI/2011/12/002260
- Lead Sponsor
- ational AIDS Control Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Subjects aged over 18 years, who had seven or fewer days of cumulative previous ART (unless taken during pregnancy to prevent mother-to-child-transmission), and who had not started ATT or received less than 14 days of the same, were eligible for entry into this study. Both confirmed and probable diagnoses of TB were permitted for inclusion.
Exclusion Criteria
Exclusion criteria were pregnancy, concomitant diabetes mellitus, epilepsy, severe illness (e.g. loss of consciousness, severe hempotysis etc.), and multi-drug resistant TB (MDR - TB).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end points of the study were death from any cause and antiretroviral treatment failure, as a measure of progression of HIV disease.Timepoint: April, 2006 to March 2011
- Secondary Outcome Measures
Name Time Method The secondary end points of the study were defined by safety and tolerability of ARV therapy, as assessed by the incidence of adverse events and proportion of subjects changing/ discontinuing ARV therapy because of the same.Timepoint: April, 2006 to March 2011