HIV InfectionsNCT00023361
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
A study testing Rifabutin in people with HIV Infections and Tuberculosis, run by Centers for Disease Control and Prevention at 23 sites in 2 countries.
Trial summary
Primary objective: To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Rifabutin
- How many people
- 215 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Feb 1999to Feb 2003
- 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
- Clinical diagnosis of pulmonary \&/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
- Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
- Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
- > 18 years of age
- Willingness to practice effective contraception if applicable
- Signed informed consent
Who cannot join
- Pregnancy or breastfeeding
- AST > 10 times the upper limit of normal
- Bilirubin > 3.0 times the upper limit of normal
- Creatinine > 3.0 times the upper limit of normal
- Intolerance to any of the study drugs except isoniazid or pyrazinamide
- Concomitant disorder that is contraindication to the use of the study drugs
- More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
- Bone/joint tuberculosis or silicotuberculosis
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
Primary objective:
To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Rifabutin
- Keywords
- tuberculosis, TB
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifabutinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of confirmed treatment failure and relapse
Secondary outcomes (3)
Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions
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 startFeb 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 HIV InfectionsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Investigators
- William Burman, MD, Study chair, Denver Health and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023361
- Sponsor's protocol ID
- CDC-NCHSTP-2174
- Other IDs
- TBTC STUDY 23
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2001
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. doi: 10.1086/429321. Epub 2005 Apr 14.
PubMed 15844071
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
- ClinicalTrials.gov ID
- NCT00023361
- Acronym / sponsor ID
- CDC-NCHSTP-2174
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- tuberculosis, TB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Feb 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.
Primary objective:
To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of pulmonary \&/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
- Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
- Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
- > 18 years of age
- Willingness to practice effective contraception if applicable
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- AST > 10 times the upper limit of normal
- Bilirubin > 3.0 times the upper limit of normal
- Creatinine > 3.0 times the upper limit of normal
- Intolerance to any of the study drugs except isoniazid or pyrazinamide
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 |
|---|---|---|
| Rifabutin | Drug | – |
Primary outcome
Rate of confirmed treatment failure and relapse
3 secondary outcomes
Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions
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 5 Sep 2005.
- Background: PubMed 15844071Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. doi: 10.1086/429321. Epub 2005 Apr 14.
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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.
William Burman, MD study chair
Denver Health and Hospitals
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifabutin in people with HIV Infections and 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 6 inclusion and 8 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 5 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?
Rate of confirmed treatment failure and relapse. 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 NCT00023361, 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 5 Sep 2005.