TuberculosisNCT00023387
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
A study testing Rifapentine, 25-desacetyl Rifapentine and Isoniazid in people with Tuberculosis, run by Centers for Disease Control and Prevention at 23 sites in 2 countries.
Trial summary
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the… 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, 25-desacetyl Rifapentine and Isoniazid
- How many people
- 36 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Mar 2000to May 2001
- Phase
- Interventional
- 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
Who may be able to join
- Patients enrolled in TBTC Study 25 Informed consent
Who cannot join
- Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25
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: Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
Read the detailed description
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.
- Conditions
- Tuberculosis
- Being tested
- Rifapentine, 25-desacetyl Rifapentine, Isoniazid
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifapentineDrug
25-desacetyl RifapentineDrug
IsoniazidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Secondary outcomes (1)
Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
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 startMar 2000
- Study completionMay 2001
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Investigators
- Marc Weiner, MD, Principal investigator, Audie L. Murphy VA Medical Center, San Antonio TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023387
- Sponsor's protocol ID
- CDC-NCHSTP-2558
- Other IDs
- TBTC Study 25PK
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2001
- Last updated
- 13 Sep 2005
- Results posted
- No
Publications
Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12.
PubMed 14962821
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
- Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
- ClinicalTrials.gov ID
- NCT00023387
- Acronym / sponsor ID
- CDC-NCHSTP-2558
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Mar 2000
- Study completion
- May 2001
- 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.
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
Detailed description
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.
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
Key inclusion criteria (1 listed)
- Patients enrolled in TBTC Study 25 Informed consent
Key exclusion criteria (1 listed)
- Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25
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 | – |
| 25-desacetyl Rifapentine | Drug | – |
| Isoniazid | Drug | – |
Primary outcome
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
1 secondary outcome
Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
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.
- Background: PubMed 14962821Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12.
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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.
Marc Weiner, MD principal investigator
Audie L. Murphy VA Medical Center, San Antonio TX
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifapentine, 25-desacetyl Rifapentine and Isoniazid 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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.
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?
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg. 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 NCT00023387, 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.