TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

Phase 2

Completed

• Conditions: HIV Infections; Tuberculosis

• Registration Number: NCT00023413
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2001-09-06
• Study First Submitted QC: 2001-09-08
• Study First Posted: 2001-09-10
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz

Secondary Outcome Measures

Name	Time	Method
*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

Trial Locations

Locations (23)

Chicago VA Medical Center (Lakeside); 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Thomas Street Clinic; 🇺🇸 Houston, Texas, United States

Central Arkansas Veterans Health System; 🇺🇸 Little Rock, Arkansas, United States

Denver Department of Public Health and Hospitals; 🇺🇸 Denver, Colorado, United States

Washington, D.C. VAMC; 🇺🇸 Washington, District of Columbia, United States

Hines VA Medical Center; 🇺🇸 Hines, Illinois, United States

New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Columbia University/Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Harlem Hospital Center; 🇺🇸 New York, New York, United States

Nashville VA Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Seattle King County Health Department; 🇺🇸 Seattle, Washington, United States

Montreal Chest Institute McGill University; 🇨🇦 Montreal, Quebec, Canada

LA County/USC Medical Center; 🇺🇸 Los Angeles, California, United States

University of North Texas Health Science Center; 🇺🇸 Fort Worth, Texas, United States

Audi L. Murphy VA Hospital; 🇺🇸 San Antonio, Texas, United States

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States