TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment

Inclusion Criteria

• •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.