A Randomized Controlled Clinical Trial Comparing Daily Vs. Intermittent 6 ? month Short Course Chemotherapy in Reducing Failures & Emergence of Acquired Rifampicin Resistance (ARR) in Patients with HIV and Pulmonary Tuberculosis

Tuberculosis Research Centre ICMR0 个研究点目标入组 420 人开始时间: 待定最近更新: 2021年11月24日

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•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.

发起方

Tuberculosis Research Centre ICMR