A clinical trial intended to compare the treatment effect of two antituberculosis regimens, daily and intermittent regimens in HIV patients with Pulmonary TB.
- Conditions
- Health Condition 1: null- culture positive Pulmonary Tuberculosis in HIV
- Registration Number
- CTRI/2009/091/000476
- Lead Sponsor
- Tuberculosis Research Centre ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 420
Age above 18 years
HIV-1/2 infected patients with Pulmonary TB
This includes, Sputum smear positive disease and initially smear negative but with Chest x-ray showing persistent abnormality after antibiotics)
Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed.
Likely to remain in the same area for at least one and half years after start of treatment
Willing for house visits and surprise checks.
Willing to participate and give informed consent after going through the terms and conditions of the trial.
Patients with known hypersensitivity to rifampicin
Pregnancy and lactation at initial presentation
Major complications like HIV encephalopathy, renal dysfunction ( serum creatinine > 1.5 mg% in the absence of dehydration )or jaundice ( serum bilirubin > 2mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal )
Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment.
Moribund, bedridden or unconscious patients
Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation
Major psychiatric illness
Patients on second line ART, mainly protease inhibitors, at initial presentation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method