TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
- Conditions
- HIV InfectionsTuberculosis
- Registration Number
- NCT00023400
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (23)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Chicago VA Medical Center (Lakeside)
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, United States
Audi L. Murphy VA Hospital
🇺🇸San Antonio, Texas, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Hines VA Medical Center
🇺🇸Hines, Illinois, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
Washington, D.C. VAMC
🇺🇸Washington, District of Columbia, United States
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Columbia University/Presbyterian Medical Center
🇺🇸New York, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
Seattle King County Health Department
🇺🇸Seattle, Washington, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada