Status:
COMPLETED
Efficacy of Thrice Weekly Directly Observed Treatment, Short-course (DOTS) in HIV-associated Tuberculosis
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Ministry of Health & Family Welfare, India
Conditions:
HIV Infections
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommen...
Detailed Description
Several reports have suggested that the initial response to antituberculosis chemotherapy is comparable among HIV-positive and negative populations. These series generally demonstrate that among "surv...
Eligibility Criteria
Inclusion
- Patients of either gender between 18-65 years of age
- All HIV positive and HIV negative patients suffering from confirmed tuberculosis (Cat I) will be included in the study
- Able to give written informed consent
Exclusion
- Patients already started on ATT for more than two weeks except when sputum smear positive with on going ATT
- Pregnancy
- Patients with SGOT/SGPT levels more than three times the upper limit of normal on three occasions, five times on one occasion.
- Serious form of pulmonary and extrapulmonary tuberculosis
- Concomitant diabetes mellitus
- Epilepsy
- Alcoholics
- Terminally ill patients
- Defaulters
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00698334
Start Date
April 1 2006
End Date
April 1 2011
Last Update
November 8 2011
Active Locations (1)
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1
All India Institute of Medcial Sciences
New Delhi, New Delhi, India, 110029