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| ID | Type | Description | Link |
|---|---|---|---|
| 23B |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
Primary Objective:
To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy.
Secondary Objectives:
To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis.
To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis.
To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir | Drug | |||
| Rifabutin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. |
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| Name | Affiliation | Role |
|---|---|---|
| Debra Benator, MD | Washington, D.C. VAMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Health System | Little Rock | Arkansas | 72205 | United States | ||
| LA County/USC Medical Center |
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| 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 |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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