HIV Infections Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility | - 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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Chest Institute McGill University | Montreal | Quebec |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Manitoba |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Chicago VA Medical Center (Lakeside) | Chicago | Illinois |
United States | Denver Department of Public Health and Hospitals | Denver | Colorado |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of North Texas Health Science Center | Fort Worth | Texas |
United States | Hines VA Medical Center | Hines | Illinois |
United States | Thomas Street Clinic | Houston | Texas |
United States | Central Arkansas Veterans Health System | Little Rock | Arkansas |
United States | LA County/USC Medical Center | Los Angeles | California |
United States | Nashville VA Medical Center | Nashville | Tennessee |
United States | Columbia University/Presbyterian Medical Center | New York | New York |
United States | Harlem Hospital Center | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | New Jersey Medical School | Newark | New Jersey |
United States | Audi L. Murphy VA Hospital | San Antonio | Texas |
United States | University of California, San Francisco | San Francisco | California |
United States | Seattle King County Health Department | Seattle | Washington |
United States | Washington, D.C. VAMC | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | VA Office of Research and Development |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz | |||
Secondary | *Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's | |||
Secondary | *Describe PK of efavirenz in this regimen | |||
Secondary | *Assess safety of concomitant rifabutin and efavirenz in HIV-TB |
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