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| ID | Type | Description | Link |
|---|---|---|---|
| TBTC Study 25PK |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifapentine | Drug | |||
| 25-desacetyl Rifapentine | Drug | |||
| Isoniazid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment. |
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Inclusion:
Patients enrolled in TBTC Study 25 Informed consent
Exclusion:
Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25
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| Name | Affiliation | Role |
|---|---|---|
| Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Health System | Little Rock | Arkansas | 72205 | United States | ||
| LA County/USC Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14962821 | Background | Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12. |
| Label | URL |
|---|---|
| (Click here for more information about the Tuberculosis Trials Consortium(TBTC) | View source |
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| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, San Francisco | San Francisco | California | 94110 | United States |
| Denver Department of Public Health and Hospitals | Denver | Colorado | 80204 | United States |
| Washington, D.C. VAMC | Washington D.C. | District of Columbia | 20422 | United States |
| Chicago VA Medical Center (Lakeside) | Chicago | Illinois | 60611 | United States |
| Hines VA Medical Center | Hines | Illinois | 60141 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287-0003 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| New Jersey Medical School | Newark | New Jersey | 07107-3001 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Columbia University/Presbyterian Medical Center | New York | New York | 10032 | United States |
| Harlem Hospital Center | New York | New York | 10037 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 34222 | United States |
| Nashville VA Medical Center | Nashville | Tennessee | 37212-2637 | United States |
| University of North Texas Health Science Center | Fort Worth | Texas | 76107-2699 | United States |
| Thomas Street Clinic | Houston | Texas | 77009 | United States |
| Audi L. Murphy VA Hospital | San Antonio | Texas | 78284 | United States |
| Seattle King County Health Department | Seattle | Washington | 98104 | United States |
| University of British Columbia | Vancouver | British Columbia | Canada V5Z 4R4 | Canada |
| University of Manitoba | Winnipeg | Manitoba | CANADA R3A 1R8 | Canada |
| Montreal Chest Institute McGill University | Montreal | Quebec | H2X 2P4Pq Canada | Canada |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C018421 | rifapentine |
| C032006 | 25-desacetylrifapentine |
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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