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| Sponsor: | Centers for Disease Control and Prevention |
|---|---|
| Collaborators: |
Department of Veterans Affairs Bayer National Institutes of Health (NIH) |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00164463 |
Purpose
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.
| Condition | Intervention |
|---|---|
|
Tuberculosis |
Drug: moxifloxacin (with isoniazid or ethambutol, rifampin and pyrazinamide) |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | TBTC Study 27/28 PK: Pharmacokinetic Issues in the Use of Moxifloxacin for Treatment of Tuberculosis |
| Estimated Enrollment: | 44 |
| Study Start Date: | July 2004 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For Healthy Volunteers:
Laboratory screening (if not already available) within 30 days of the first PK admission:
For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:
Exclusion Criteria:
For Healthy Volunteers:
For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:
Contacts and Locations| United States, California | |
| University of Southern California Medical Center | |
| Los Angeles, California, United States, 90033 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| University of North Texas Health Science Center | |
| Fort Worth, Texas, United States, 76104 | |
| Houston Veterans Administration Medical Center | |
| Houston, Texas, United States, 77030 | |
| Audie L Murphy Memorial Veterans Administration Medical Center | |
| San Antonio, Texas, United States, 78284 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 1L8 | |
| Uganda | |
| Makerere University Medical School | |
| Kampala, Uganda | |
| Study Chair: | Marc Weiner, MD | VAMC and University of Texas Health Science Center San Antonio |
| Study Chair: | William Burman, MD | Denver Public Health |
More Information
| Study ID Numbers: | CDC-NCHSTP-4222 |
| Study First Received: | September 10, 2005 |
| Last Updated: | August 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00164463 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
tuberculosis TB |
|
Bacterial Infections Anti-Infective Agents Pyrazinamide Actinomycetales Infections Pharmacologic Actions Anti-Bacterial Agents Gram-Positive Bacterial Infections |
Moxifloxacin Therapeutic Uses Mycobacterium Infections Tuberculosis Ethambutol Antitubercular Agents |