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Completed Phase 3 Interventional

TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

ClinicalTrials.gov ID: NCT00023335

Public ClinicalTrials.gov record NCT00023335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 4:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Study identification

NCT ID
NCT00023335
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,000 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 1995 (Type not available)
Primary completion
Not listed
Completion
Mar 2001 (Type not available)
Last update posted
Sep 5, 2005

1995 – 2001

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
18
Facility City State ZIP Site status
Central Arkansas Veterans Health System Little Rock Arkansas 72205 —
LA County/USC Medical Center Los Angeles California 90033 —
University of California, San Francisco San Francisco California 94110 —
Denver Department of Public Health and Hospitals Denver Colorado 80204 —
Washington, D.C. VAMC Washington D.C. District of Columbia 20422 —
Chicago VA Medical Center (Lakeside) Chicago Illinois 60611 —
Hines VA Medical Center Hines Illinois 60141 —
Johns Hopkins University School of Medicine Baltimore Maryland 21287-0003 —
Boston Medical Center Boston Massachusetts 02118 —
New Jersey Medical School Newark New Jersey 07107-3001 —
New York University School of Medicine New York New York 10016 —
Columbia University/Presbyterian Medical Center New York New York 10032 —
Harlem Hospital Center New York New York 10037 —
Carolinas Medical Center Charlotte North Carolina 28203 —
Duke University Medical Center Durham North Carolina 34222 —
Nashville VA Medical Center Nashville Tennessee 37212-2637 —
University of North Texas Health Science Center Fort Worth Texas 76107-2699 —
Thomas Street Clinic Houston Texas 77009 —
Audi L. Murphy VA Hospital San Antonio Texas 78284 —
Seattle King County Health Department Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00023335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 5, 2005 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00023335 live on ClinicalTrials.gov.

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