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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.
VA Office of Research and Development
Information provided by:
Centers for Disease Control and Prevention Identifier:
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005
Randomized, double-blind study of the tolerability of three different doses of rifapentine

Condition Intervention Phase
Drug: rifapentine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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


  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
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Please refer to this study by its identifier: NCT00023426

  Show 23 Study Locations
Sponsors and Collaborators
Centers for Disease Control and Prevention
VA Office of Research and Development
Principal Investigator: Naomi Bock, MD Centers for Disease Control & Prevention
  More Information

Additional Information:
Publications: Identifier: NCT00023426     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2404
Study First Received: September 6, 2001
Last Updated: September 9, 2005

Keywords provided by Centers for Disease Control and Prevention:

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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 processed this record on May 22, 2017