Efficacy of Thrice Weekly Directly Observed Treatment, Short-course (DOTS) in HIV-associated Tuberculosis

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

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

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: Ministry of Health & Family Welfare, India
• Treatments: Ethambutol; Pyrazinamide; Rifampin

Criteria

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