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)
Central Arkansas Veterans Health System
πΊπΈLittle Rock, Arkansas, United States
LA County/USC Medical Center
πΊπΈLos Angeles, California, United States
University of California, San Francisco
πΊπΈSan Francisco, California, United States
Denver Department of Public Health and Hospitals
πΊπΈDenver, Colorado, United States
Washington, D.C. VAMC
πΊπΈWashington, District of Columbia, United States
Chicago VA Medical Center (Lakeside)
πΊπΈChicago, Illinois, United States
Hines VA Medical Center
πΊπΈHines, Illinois, United States
Johns Hopkins University School of Medicine
πΊπΈBaltimore, Maryland, United States
Boston Medical Center
πΊπΈBoston, Massachusetts, United States
New Jersey Medical School
πΊπΈNewark, New Jersey, United States
Scroll for more (13 remaining)Central Arkansas Veterans Health SystemπΊπΈLittle Rock, Arkansas, United States