TuberculosisPhase 2NCT00023426
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
A Phase 2 study testing rifapentine in people with Tuberculosis, run by Centers for Disease Control and Prevention at 23 sites in 2 countries.
Trial summary
Randomized, double-blind study of the tolerability of three different doses of rifapentine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- rifapentine
- How many people
- 150 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 1999to Feb 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0003
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28203
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 34222
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699
Hines VA Medical Center
Hines, Illinois, 60141
Thomas Street Clinic
Houston, Texas, 77009
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205
LA County/USC Medical Center
Los Angeles, California, 90033
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637
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
New Jersey Medical School
Newark, New Jersey, 07107-3001
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284
University of California, San Francisco
San Francisco, California, 94110
Seattle King County Health Department
Seattle, Washington, 98104
Washington, D.C. VAMC
Washington D.C., District of Columbia, 20422
Canada3 sites
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8
About this study
Official title: 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
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- rifapentine
- Keywords
- tuberculosis, tb, rifapentine, safety, dose
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifapentineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2001 (estimated)
- Study startJul 1999
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Naomi Bock, MD, Principal investigator, Centers for Disease Control & Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023426
- Sponsor's protocol ID
- CDC-NCHSTP-2404
- Other IDs
- HCK45, 25
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2001
- Last updated
- 13 Sep 2005
- Results posted
- No
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. doi: 10.1164/rccm.200201-047OC.
PubMed 12045127
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
- ClinicalTrials.gov ID
- NCT00023426
- Acronym / sponsor ID
- CDC-NCHSTP-2404
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, tb, rifapentine, safety, dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Jul 1999
- Study completion
- Feb 2003
- First posted
- 10 Sep 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind study of the tolerability of three different doses of rifapentine
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rifapentine | Drug | – |
Primary outcome
Proportion of patients who fail to complete therapy in each of the dosing groups
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2005.
- Results publication: PubMed 12045127Bock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Bock, MD principal investigator
Centers for Disease Control & Prevention
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rifapentine in people with Tuberculosis, run by Centers for Disease Control and Prevention at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who fail to complete therapy in each of the dosing groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2005.