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

NCT ID: NCT00023413

Last Updated: 2012-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2004-02-29

Brief Summary

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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

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Conditions

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HIV Infections Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rifabutin

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio VAMC, San Antonio TX

Locations

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Central Arkansas Veterans Health System

Little Rock, Arkansas, United States

Site Status

LA County/USC Medical Center

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Denver Department of Public Health and Hospitals

Denver, Colorado, United States

Site Status

Washington, D.C. VAMC

Washington D.C., District of Columbia, United States

Site Status

Chicago VA Medical Center (Lakeside)

Chicago, Illinois, United States

Site Status

Hines VA Medical Center

Hines, Illinois, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

New Jersey Medical School

Newark, New Jersey, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Columbia University/Presbyterian Medical Center

New York, New York, United States

Site Status

Harlem Hospital Center

New York, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Nashville VA Medical Center

Nashville, Tennessee, United States

Site Status

University of North Texas Health Science Center

Fort Worth, Texas, United States

Site Status

Thomas Street Clinic

Houston, Texas, United States

Site Status

Audi L. Murphy VA Hospital

San Antonio, Texas, United States

Site Status

Seattle King County Health Department

Seattle, Washington, United States

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Montreal Chest Institute McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.cdc.gov/nchstp/tb/tbtc/

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

Other Identifiers

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23C

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-2588

Identifier Type: -

Identifier Source: org_study_id

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