HIV Infections Clinical Trial
Official title:
TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility | - Patients with HIV-related tuberculosis |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Chest Institute McGill University | Montreal | Quebec |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Manitoba |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Chicago VA Medical Center (Lakeside) | Chicago | Illinois |
United States | Denver Department of Public Health and Hospitals | Denver | Colorado |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of North Texas Health Science Center | Fort Worth | Texas |
United States | Hines VA Medical Center | Hines | Illinois |
United States | Thomas Street Clinic | Houston | Texas |
United States | Central Arkansas Veterans Health System | Little Rock | Arkansas |
United States | LA County/USC Medical Center | Los Angeles | California |
United States | Nashville VA Medical Center | Nashville | Tennessee |
United States | Columbia University/Presbyterian Medical Center | New York | New York |
United States | Harlem Hospital Center | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | New Jersey Medical School | Newark | New Jersey |
United States | Audi L. Murphy VA Hospital | San Antonio | Texas |
United States | University of California, San Francisco | San Francisco | California |
United States | Seattle King County Health Department | Seattle | Washington |
United States | Washington, D.C. VAMC | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | VA Office of Research and Development |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |||
Secondary | 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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