- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023413
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
TBTC Study 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study.
Primary Objective:
To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, Canada V5Z 4R4
- University of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, CANADA R3A 1R8
- University of Manitoba
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Quebec
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Montreal, Quebec, Canada, H2X 2P4Pq Canada
- Montreal Chest Institute McGill University
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-
-
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Health System
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California
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Los Angeles, California, United States, 90033
- LA County/USC Medical Center
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San Francisco, California, United States, 94110
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver Department of Public Health and Hospitals
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Washington, D.C. VAMC
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Illinois
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Chicago, Illinois, United States, 60611
- Chicago VA Medical Center (Lakeside)
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Hines, Illinois, United States, 60141
- Hines VA Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287-0003
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New Jersey
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Newark, New Jersey, United States, 07107-3001
- New Jersey Medical School
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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New York, New York, United States, 10037
- Harlem Hospital Center
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New York, New York, United States, 10032
- Columbia University/Presbyterian Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
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Durham, North Carolina, United States, 34222
- Duke University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Nashville VA Medical Center
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Texas
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Fort Worth, Texas, United States, 76107-2699
- University of North Texas Health Science Center
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Houston, Texas, United States, 77009
- Thomas Street Clinic
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San Antonio, Texas, United States, 78284
- Audi L. Murphy VA Hospital
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Washington
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Seattle, Washington, United States, 98104
- Seattle King County Health Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz
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Secondary Outcome Measures
Outcome Measure |
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*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
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*Describe PK of efavirenz in this regimen
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*Assess safety of concomitant rifabutin and efavirenz in HIV-TB
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marc Weiner, MD, San Antonio VAMC, San Antonio TX
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Infections
- Tuberculosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Rifabutin
- Efavirenz
Other Study ID Numbers
- CDC-NCHSTP-2588
- 23C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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