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Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis

NCT00933790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2019-04-10

No results posted yet for this study

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 intermittent regimens. The study would generate data on the efficacy of daily and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and adverse drug reaction between daily and intermittent regimens of ATT in HIV positive patients. This study provides a unique opportunity for comparison of daily and intermittent therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB treatment namely efficacy, drug resistance, toxicity , drug interaction and immune reconstitution inflammatory syndrome. The primary outcome of the study is to compare the efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution syndrome.

Conditions

  • HIV Infection
  • Pulmonary TB

Interventions

DRUG

ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)

Ethambutol 800 mg for daily, 1200 mg for intermittent therapy, Pyrazinamide 1500 mg for both daily and intermittent, INH 300 mg for daily and 600 mg for intermittent therapy, Rifampicin 450 mg for both daily and intermittent therapy for patients below 60 kg, 600 mg for both daily and intermittent therapy for patients 60 kg and above

Sponsors & Collaborators

  • Tuberculosis Research Centre, India

    lead OTHER_GOV

Principal Investigators

  • Narendran Gopalan, DNB (Chest) · Scientist 'B', Tuberculosis Research Centre (ICMR), Chennai, India

  • Soumya Swaminathan, MD · Scientist 'F', Tuberculosis Research Centre (ICMR), Chennai, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-14
Primary Completion
2016-12-31
Completion
2018-06-30

Countries

  • India

Study Locations

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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 NCT00933790 on ClinicalTrials.gov