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

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ClinicalTrials.gov Identifier: NCT00023335
Recruitment Status : Completed
First Posted : September 10, 2001
Last Update Posted : September 5, 2005
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:

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 or disease Intervention/treatment Phase
Pulmonary Tuberculosis Drug: Rifapentine Drug: Isoniazid Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 1995
Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Culture-positive, drug-susceptible pulmonary tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023335


  Show 23 Study Locations
Sponsors and Collaborators
Centers for Disease Control and Prevention
VA Office of Research and Development

Additional Information:
Publications:
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
First Posted: September 10, 2001    Key Record Dates
Last Update Posted: September 5, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Isoniazid
Rifapentine
Rifampin
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antibiotics, Antitubercular
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers