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TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

This study has been completed.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Department of Veterans Affairs
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00023426
  Purpose

Randomized, double-blind study of the tolerability of three different doses of rifapentine


Condition Intervention Phase
Tuberculosis
Drug: rifapentine
Phase II

MedlinePlus related topics:   Tuberculosis   

Drug Information available for:   Rifapentine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
Official Title:   TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

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

Primary Outcome Measures:
  • Proportion of patients who fail to complete therapy in each of the dosing groups

Secondary Outcome Measures:
  • 1. Rate of serious adverse events in each of the dosing groups
  • 2. Rate of total adverse events in each of the groups
  • 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

Estimated Enrollment:   150
Study Start Date:   July 1999
Estimated Study Completion Date:   February 2003

Detailed Description:

Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusions:

  1. Drug susceptible culture-positive tuberculosis
  2. Adequate induction therapy
  3. Age >18
  4. Normal screening labs
  5. Karnofsky >=60
  6. Informed consent
  7. Birth control if of child bearing potential

Exclusions:

  1. SilicoTB
  2. Skeletal or CNS TB
  3. Pregnant or breastfeeding
  4. Intolerance to INH or rifamycins
  5. Over 70 days TB treatment just prior to enrollment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023426

Show 23 study locations  Show 23 Study Locations

Sponsors and Collaborators

Investigators
Principal Investigator:     Naomi Bock, MD     Centers for Disease Control & Prevention    
  More Information


(Click here for more information about the Tuberculosis Trials Consortium(TBTC)  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDC-NCHSTP-2404, HCK45, 25
First Received:   September 6, 2001
Last Updated:   September 9, 2005
ClinicalTrials.gov Identifier:   NCT00023426
Health Authority:   United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
tuberculosis  
tb  
rifapentine  
safety  
dose  

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Rifapentine
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Antitubercular Agents
Pharmacologic Actions
Actinomycetales Infections
Leprostatic Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on December 03, 2008




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