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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023413
First received: September 6, 2001
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Tuberculosis
Drug: Rifabutin
Drug: Efavirenz
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Secondary Outcome Measures:
  • *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

Estimated Enrollment: 20
Study Start Date: November 1999
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023413

  Hide Study Locations
Locations
United States, Arkansas
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
United States, California
LA County/USC Medical Center
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver Department of Public Health and Hospitals
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington, D.C. VAMC
Washington, District of Columbia, United States, 20422
United States, Illinois
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States, 60611
Hines VA Medical Center
Hines, Illinois, United States, 60141
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-0003
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07107-3001
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Columbia University/Presbyterian Medical Center
New York, New York, United States, 10032
Harlem Hospital Center
New York, New York, United States, 10037
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 34222
United States, Tennessee
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107-2699
Thomas Street Clinic
Houston, Texas, United States, 77009
Audi L. Murphy VA Hospital
San Antonio, Texas, United States, 78284
United States, Washington
Seattle King County Health Department
Seattle, Washington, United States, 98104
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, Canada V5Z 4R4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, CANADA R3A 1R8
Canada, Quebec
Montreal Chest Institute McGill University
Montreal, Quebec, Canada, H2X 2P4Pq Canada
Sponsors and Collaborators
Investigators
Principal Investigator: Marc Weiner, MD San Antonio VAMC, San Antonio TX
  More Information

Additional Information:
No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00023413     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2588, 23C
Study First Received: September 6, 2001
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
tuberculosis
TB

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Rifabutin
Efavirenz
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on August 28, 2014