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

NCT ID: NCT00023426

Last Updated: 2005-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2003-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis

Keywords

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tuberculosis tb rifapentine safety dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rifapentine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Naomi Bock, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control & Prevention

Locations

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Central Arkansas Veterans Health System

Little Rock, Arkansas, United States

Site Status

LA County/USC Medical Center

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Denver Department of Public Health and Hospitals

Denver, Colorado, United States

Site Status

Washington, D.C. VAMC

Washington D.C., District of Columbia, United States

Site Status

Chicago VA Medical Center (Lakeside)

Chicago, Illinois, United States

Site Status

Hines VA Medical Center

Hines, Illinois, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

New Jersey Medical School

Newark, New Jersey, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Columbia University/Presbyterian Medical Center

New York, New York, United States

Site Status

Harlem Hospital Center

New York, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Nashville VA Medical Center

Nashville, Tennessee, United States

Site Status

University of North Texas Health Science Center

Fort Worth, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Audi L. Murphy VA Hospital

San Antonio, Texas, United States

Site Status

Seattle King County Health Department

Seattle, Washington, United States

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Montreal Chest Institute McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1164/rccm.200201-047OC.

Reference Type RESULT
PMID: 12045127 (View on PubMed)

Related Links

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http://www.cdc.gov/nchstp/tb/tbtc/

(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Other Identifiers

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HCK45

Identifier Type: -

Identifier Source: secondary_id

25

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-2404

Identifier Type: -

Identifier Source: org_study_id