Status:
COMPLETED
Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis
Lead Sponsor:
Tuberculosis Research Centre, India
Conditions:
HIV Infection
Pulmonary TB
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 i...
Detailed Description
HIV positive patients (regardless of ART status) with newly diagnosed pulmonary TB attending the TRC clinics at Chennai, Madurai and Vellore will form the study group. Those who fulfill the clinical i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00933790
Start Date
September 14 2009
End Date
June 30 2018
Last Update
April 10 2019
Active Locations (3)
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1
Tuberculosis Research Centre (ICMR)
Chennai, Tamil Nadu, India, 600 031
2
Govt. Hospital of Thoracic Medicine, Tambaram
Chennai, Tamil Nadu, India, 600 047
3
Tuberculosis Research Centre (ICMR)
Madurai, Tamil Nadu, India, 625 020