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TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023335
First received: September 6, 2001
Last updated: September 1, 2005
Last verified: September 2005
  Purpose

Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.

Secondary Objectives:

To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.

To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.

To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.

To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.

To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.

To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.

To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.


Condition Intervention Phase
Pulmonary Tuberculosis
Drug: Rifapentine
Drug: Isoniazid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Estimated Enrollment: 1000
Study Start Date: April 1995
Estimated Study Completion Date: March 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Culture-positive, drug-susceptible pulmonary tuberculosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023335

  Show 23 Study Locations
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00023335     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1427, TBTC Study 22
Study First Received: September 6, 2001
Last Updated: September 1, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Mycobacterium Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Isoniazid
Rifapentine
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Leprostatic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014