Smear Positive, Pan-sensitive, Pulmonary Tuberculosis Clinical Trial
— TBTC-29PKOfficial title:
Pharmacokinetic and Pharmacodynamic Studies of Efficacy, Tolerability and Safety of Higher Dosage Rifapentine for Treatment of Tuberculosis
The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any patient enrolled in TBTC Study 29. - Provision of informed consent for the study. - Willingness to be sampled in an out-patient clinic or be admitted to a General Clinical Research Center (GCRC) or hospital on one occasion Exclusion Criteria: • Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study). |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | University of KwaZulu Natal | Durban | |
Uganda | Uganda / Case Western Reserve Research Collaboration | Kampala | |
United States | University of North Texas | Denton | Texas |
United States | Denver Public Health | Denver | Colorado |
United States | TBTC site 40 / South Texas | Harlingen | Texas |
United States | Audie L. Murphy VA Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention |
United States, South Africa, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of this study is to characterize rifapentine pharmacokinetic parameters (AUC0-24 and peak concentration) in patients with TB. | on or after the 10th day from the start of Study 29 therapy | No | |
Secondary | • To assess the pharmacodynamic effects of higher dose, daily rifapentine AUC0-24 on tolerability and safety during two months of treatment of tuberculosis. | on or after the 10th day of study therapy | Yes | |
Secondary | • To assess the pharmacodynamic effect of rifapentine pharmacokinetic parameters (AUC0-24) on biomarkers of treatment activity in patients with tuberculosis. | on or after the 10th day of study therapy | No | |
Secondary | • To assess in multivariate analyses the pharmacodynamic effect on biomarkers of treatment activity of the independent variables of rifapentine AUC0-24, HIV infection, isoniazid exposure (AUC0-12) and study site (African vs. non-African). | on or after the 10th day of study therapy | No | |
Secondary | To determine if free (non-protein bound) rifapentine and free rifampin exposures are directly associated with anti-mycobacterial activity. | on or after the 10th day of study therapy | No | |
Secondary | • To determine the effects of polymorphisms of transporter genes on rifampin and rifapentine pharmacokinetic parameters. | on or after the 10th day of therapy | No |