TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Rifapentine

U.S. FDA Resources

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:

Drug susceptible culture-positive tuberculosis
Adequate induction therapy
Age >18
Normal screening labs
Karnofsky >=60
Informed consent
Birth control if of child bearing potential

Exclusions:

SilicoTB
Skeletal or CNS TB
Pregnant or breastfeeding
Intolerance to INH or rifamycins
Over 70 days TB treatment just prior to enrollment

Contacts and Locations

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

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Locations

United States, Arkansas
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
United States, California
LA County/USC Medical Center
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver Department of Public Health and Hospitals
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington, D.C. VAMC
Washington, District of Columbia, United States, 20422
United States, Illinois
Hines VA Medical Center
Hines, Illinois, United States, 60141
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-0003
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07107-3001
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Columbia University/Presbyterian Medical Center
New York, New York, United States, 10032
Harlem Hospital Center
New York, New York, United States, 10037
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 34222
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Tennessee
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107-2699
Thomas Street Clinic
Houston, Texas, United States, 77009
Audi L. Murphy VA Hospital
San Antonio, Texas, United States, 78284
United States, Washington
Seattle King County Health Department
Seattle, Washington, United States, 98104
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, Canada V5Z 4R4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, CANADA R3A 1R8
Canada, Quebec
Montreal Chest Institute McGill University
Montreal, Quebec, Canada, H2X 2P4Pq Canada

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators

Principal Investigator:

Naomi Bock, MD

Centers for Disease Control & Prevention

More Information

Additional Information:

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

Publications:

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.

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

Bacterial Infections
Anti-Infective Agents
Rifapentine
Actinomycetales Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents

Gram-Positive Bacterial Infections
Therapeutic Uses
Mycobacterium Infections
Tuberculosis
Antitubercular Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 30, 2009