TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
Completed · Phase 4
Conditions studied: HIV Infections, Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT00023400
- Run by
- Centers for Disease Control and Prevention
- People needed
- 20
- Starts
- 2000-02-01
- Expected to finish
- 2002-02-01
- Last updated by the study team
- 2005-09-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Central Arkansas Veterans Health System — Little Rock, Arkansas, United States
- LA County/USC Medical Center — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Denver Department of Public Health and Hospitals — Denver, Colorado, United States
- Washington, D.C. VAMC — Washington D.C., District of Columbia, United States
- Chicago VA Medical Center (Lakeside) — Chicago, Illinois, United States
- Hines VA Medical Center — Hines, Illinois, United States
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Boston Medical Center — Boston, Massachusetts, United States
- New Jersey Medical School — Newark, New Jersey, 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
- Harlem Hospital Center — New York, New York, United States
- Carolinas Medical Center — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Nashville VA Medical Center — Nashville, Tennessee, United States
- University of North Texas Health Science Center — Fort Worth, Texas, United States
- Thomas Street Clinic — Houston, Texas, United States
- Audi L. Murphy VA Hospital — San Antonio, Texas, United States
- Seattle King County Health Department — Seattle, Washington, United States
- University of British Columbia — Vancouver, British Columbia, Canada
- University of Manitoba — Winnipeg, Manitoba, Canada
- Montreal Chest Institute McGill University — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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