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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023426
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Tuberculosis
Drug: rifapentine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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.

  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
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: NCT00023426

  Show 23 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Naomi Bock, MD Centers for Disease Control & Prevention
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00023426     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2404, HCK45, 25
Study First Received: September 6, 2001
Last Updated: September 9, 2005
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

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifapentine
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Leprostatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014