Status:
COMPLETED
TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
US Department of Veterans Affairs
Bayer
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 moxif...
Eligibility Criteria
Inclusion
- For Healthy Volunteers:
- Provision of informed consent for the study.
- Age \> 18 years.
- Willingness to be available for 2 weeks of DOT.
- Willingness to be admitted to a GCRC or hospital on two occasions.
- Women of child-bearing potential must agree to practice an adequate method of birth control. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods.
- Willingness to have HIV testing done if documented results are not available. (A prior negative result must be obtained within one year and consists of a negative HIV ELISA. A positive result must be both a positive HIV ELISA and Western Blot, or a plasma HIV PCR RNA level greater than 5000 copies/ml).
- Laboratory screening (if not already available) within 30 days of the first PK admission:
- Serum potassium within normal limits
- Hematocrit \> 35%
- Absolute neutrophil count \> 1000 /mm3
- AST \< 3 times the upper limit of normal
- Bilirubin \< 2 times the upper limit of normal
- Creatinine \< 2 times the upper limit of normal
- Eligible and enrolled for medical health care sponsored by the United States federal government (such as the Veterans Administration enrollment Priority 1 through 7, VHA Directive 2003-003).
- For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:
- Any patient enrolled in TBTC Study 27 or Study 28 receiving a daily (5-7 days per week) regimen.
- Provision of informed consent for the study.
- Willingness to be admitted to a GCRC or hospital on one occasion.
Exclusion
- For Healthy Volunteers:
- Karnofsky score less than 90
- Pregnancy or breast-feeding. (A negative pregnancy test is required for women of childbearing potential within 14 days before the first dose of moxifloxacin.)
- Known allergy to any fluoroquinolone or rifamycin antibiotic
- Current or planned therapy during the study with drugs having unacceptable interactions with rifampin
- History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during period of administration of moxifloxacin and for one week after treatment
- For Patients with Tuberculosis Enrolled in TBTC Study 27 or Study 28:
- Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
- History of severe liver disease classified as Child Pugh Class C.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00164463
Start Date
July 1 2004
End Date
August 1 2007
Last Update
June 8 2011
Active Locations (8)
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1
University of Southern California Medical Center
Los Angeles, California, United States, 90033
2
Johns Hopkins University
Baltimore, Maryland, United States, 21231
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76104