HIV Infections Clinical Trial
Official title:
Efficacy of Thrice Weekly Intermittent Short Course Antituberculosis Chemotherapy in Tuberculosis Patients With and Without HIV Infection
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 recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2011 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medcial Sciences | New Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi | Ministry of Health & Family Welfare, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rate | 6 months | No | |
Secondary | Treatment failure | 6 months | No | |
Secondary | Death | 12 monts | No | |
Secondary | Relapse | 12 months | No | |
Secondary | Adverse drug reactions | 6 months | Yes |
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