TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
NCT ID: NCT00023400
Last Updated: 2005-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2000-02-29
2002-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nelfinavir
Rifabutin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
0 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Centers for Disease Control and Prevention
FED
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Debra Benator, MD
Role: STUDY_CHAIR
Washington, D.C. VAMC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
(Click here for more information about the Tuberculosis Trials Consortium(TBTC)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23B
Identifier Type: -
Identifier Source: secondary_id
CDC-NCHSTP-2587
Identifier Type: -
Identifier Source: org_study_id