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
2 other identifiers
interventional
20
2 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
Started Nov 1999
Typical duration for phase_2 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 6, 2001
CompletedFirst Posted
Study publicly available on registry
September 10, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedJune 5, 2012
June 1, 2012
4.3 years
September 6, 2001
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz
Secondary Outcomes (3)
*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
*Describe PK of efavirenz in this regimen
*Assess safety of concomitant rifabutin and efavirenz in HIV-TB
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (23)
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205, United States
LA County/USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94110, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204, United States
Washington, D.C. VAMC
Washington D.C., District of Columbia, 20422, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0003, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
New Jersey Medical School
Newark, New Jersey, 07107-3001, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University/Presbyterian Medical Center
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 34222, United States
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284, United States
Seattle King County Health Department
Seattle, Washington, 98104, United States
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4, Canada
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8, Canada
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Weiner, MD
San Antonio VAMC, San Antonio TX
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2001
First Posted
September 10, 2001
Study Start
November 1, 1999
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
June 5, 2012
Record last verified: 2012-06