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

Condition(s) targeted: HIV Infections; Tuberculosis

Intervention: Rifabutin (Drug); Efavirenz (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Marc Weiner, MD, Principal Investigator, Affiliation: San Antonio VAMC, San Antonio TX

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz

Secondary outcome:

*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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- 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.

Central Arkansas Veterans Health System, Little Rock, Arkansas 72205, United States

University of British Columbia, Vancouver, British Columbia Canada V5Z 4R4, Canada

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, District of Columbia 20422, United States

Hines VA Medical Center, Hines, Illinois 60141, United States

Chicago VA Medical Center (Lakeside), Chicago, Illinois 60611, United States

University of Manitoba, Winnipeg, Manitoba CANADA R3A 1R8, Canada

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

Duke University Medical Center, Durham, North Carolina 34222, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Montreal Chest Institute McGill University, Montreal, Quebec H2X 2P4Pq Canada, Canada

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

(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Starting date: November 1999
Last updated: September 1, 2005