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View Clinical Trial (Medical Research Study)
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TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment - NCT00694629-10032 (Clinical Trial 225627)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy225627.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Pulmonary Tuberculosis |
| Purpose: |
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Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial
activity and safety of an experimental intensive phase (first 8 weeks of treatment)
tuberculosis treatment regimen in which rifapentine is substituted for rifampin.
Primary Objective
- To compare the antimicrobial activity and safety of standard daily regimen comprised of
rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE)
to that of an experimental regimen comprised of rifapentine (approximately 10
mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE).
Secondary Objectives
- To determine and compare for each regimen the time to culture-conversion, using data
from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses).
- To determine and compare for each regimen the proportion of patients with any Grade 3
or 4 adverse reactions
- To determine the correlation of the MGIT/BACTEC liquid culture growth index and other
mycobacterial and clinical biomarkers with time to culture conversion and treatment
failure
- To store serum for future assessment of biomarkers of TB treatment response and
hypersensitivity to study drugs.
- To compare adverse events and 2-month culture conversion rates among HIV-infected
patients vs. HIV-uninfected patients
Design
This will be a prospective, multicenter, open-label clinical study. Adults suspected of
having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive
either the experimental intensive phase tuberculosis treatment regimen or the standard
intensive phase tuberculosis treatment regimen. Randomization will be stratified by
presence/absence of cavitation on baseline chest radiograph, and by geographic continent.
All doses of study drugs will be given under direct observation and administered 5 days per
week. After a subject completes intensive phase therapy, he/she then will be treated with a
non-experimental continuation phase tuberculosis treatment regimen.
Subjects will have blood drawn for one pharmacokinetic determination of rifapentine
concentration towards the end of intensive phase therapy.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of
expectorated or induced sputum.
2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the
last documented negative HIV test was more than 3 months prior to enrollment.
3. 5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months
preceding initiation of study drugs.
4. 7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding
initiation of study drugs.
5. Age >= 18 years
6. Karnofsky score of at least 60 (requires occasional assistance but is able to care
for most of his/her needs; see Appendix B)
7. Signed informed consent
8. Women of child-bearing potential must agree to practice an adequate (barrier) method
of birth control or to abstain from heterosexual intercourse during study therapy.
9. Laboratory parameters done within 14 days prior to, enrollment:
- Serum or plasma alanine aminotransferase (ALT) activity ≤ 3 times the upper
limit of normal
- Serum or plasma total bilirubin level ≤ 2.5 times the upper limit of normal
- Serum or plasma creatinine level ≤ 2 times the upper limit of normal
- Complete blood count with hemoglobin level of at least 7.0 g/dL
- Complete blood count with platelet count of at least 100,000/mm3
- Negative pregnancy test (women of childbearing potential)
Exclusion Criteria:
1. Pregnant or breast-feeding
2. Known intolerance or allergy to any of the study drugs
3. Concomitant disorders or conditions for which isoniazid (INH), rifamycins,
pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe
hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty
arthritis.
4. Current or planned therapy, during the intensive phase of TB therapy, with
combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus.
Cyclosporine and tacrolimus have unacceptable interactions with rifamycins.
5. Pulmonary silicosis
6. Central nervous system TB
7. Weight < 40 kg |
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| Study is available at: |
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Columbia University/Presbyterian Medical Center
New York, NY 10032
United States
Primary Contact:
Neil W Schluger, MD
Email: ns311@columbia.edu
Phone: 212-305-9817 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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