A randomised controlled trial of 3 strategies for the treatment of ARV naive HIV infected patients with tuberculosis
Not Applicable
Recruiting
- Conditions
- HIV/AIDSTuberculosis
- Registration Number
- PACTR201105000291300
- Lead Sponsor
- ondon School of Hygiene & Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1125
Inclusion Criteria
Main inclusion criteria:
o Male or female aged 18 or over
o ARV naïve patients HIV + with CD4 cells more than 50
o All types of TB disease with bacteriological confirmation
o Written informed consent
Exclusion Criteria
Main exclusion criteria:
o Pregnant women or lactating women or women who are unwilling to use contraception
o HIV-2 infected patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality from all causes
- Secondary Outcome Measures
Name Time Method Mortality from all causes ;Type, frequency and severity of Adverse Events (AEs) ;Percentage of TB relapse and TB recurrence ;Plasma concentrations of rifampicin, isoniazid, pyrazinamide and ethambutol