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

September 6, 2001
September 9, 2005
July 1999
Not Provided
Proportion of patients who fail to complete therapy in each of the dosing groups
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Complete list of historical versions of study NCT00023426 on ClinicalTrials.gov Archive Site
  • 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
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TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tuberculosis
Drug: rifapentine
Not Provided
Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1526-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2003
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00023426
CDC-NCHSTP-2404, HCK45, 25
Not Provided
Not Provided
Centers for Disease Control and Prevention
Department of Veterans Affairs
Principal Investigator: Naomi Bock, MD Centers for Disease Control & Prevention
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP