Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB patients. It has not been a major problem in HIV-negative individuals treated for TB treated with standard intermittent regimens. The study would generate data on the efficacy of daily and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and adverse drug reaction between daily and intermittent regimens of ATT in HIV positive patients. This study provides a unique opportunity for comparison of daily and intermittent therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB treatment namely efficacy, drug resistance, toxicity , drug interaction and immune reconstitution inflammatory syndrome. The primary outcome of the study is to compare the efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuberculosis Research Centre, India
• Treatments: Ethambutol; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• Age above 18 years.

• HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease.

• Initially smear negative but Xpert-MTB positive or LPA positive taken as a surrogate marker for culture positivity (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics). as BACTEC (Becton-Dickinson) has been phased out ,Final inclusion will only be patients positive by LJ culture

• Persistent X-ray abnormality will be included for allocation. However final inclusion into both ITT and efficacy analysis will depend on positivity in LJ culture.

• 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.

Exclusion Criteria:

• 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 > 2 mgs% 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.