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

NCT00698334 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-11-08

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Tuberculosis

Interventions

DRUG

INH, Rifampicin, Ethambutol and Pyrazinamide

Directly Observed Treatment Short-course; Thrice weekly (INH 600 mg, Rifampicin 450 mg \[600 mg if more than 59 kg\], Ethambutol 1200 mg, Pyrazinamide 1500 mg)

DRUG

INH, Rifampicin, Ethambutol and Pyrazinamide

Directly Observed Treatment Short-course; Thrice weekly (INH 600 mg, Rifampicin 450 mg \[600 mg if more than 59 kg\], Ethambutol 1200 mg, Pyrazinamide 1500 mg)

Sponsors & Collaborators

  • Ministry of Health & Family Welfare, India

    collaborator OTHER_GOV
  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Surendra K Sharma, MD. Ph.D · All India Institute of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-09-30
Completion
2011-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698334 on ClinicalTrials.gov