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TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment - NCT00694629-90033A(Clinical Trial 225614)



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City:  Los Angeles
State:  
CA
Zip Code: 90033
Conditions: Pulmonary Tuberculosis
Purpose: 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.
Study summary:
Criteria: 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
Study is available at: LA County/USC Medical Center
Los Angeles, CA 90033
United States

Primary Contact:
Brenda E Jones, MD
Email: bejones@hsc.usc.edu
Phone: 323-343-8300
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: ClinicalTrials.gov
Date Processed: March 22, 2011
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