Clinical Trials

MainTitle

TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

This study has been completed
Sponsor
Centers for Disease Control and Prevention

Collaborator
VA Office of Research and Development

Information provided by (Responsible Party)
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier
NCT00023361

First received: September 6, 2001
Last updated: September 1, 2005
Last Verified: September 2005
History of Changes
Purpose

Purpose

Primary objective:

To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).

Condition Intervention
HIV Infections
Tuberculosis

Drug : Rifabutin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

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

Primary Outcome Measures

  • Rate of confirmed treatment failure and relapse
Secondary Outcome Measures:
  • Safety and tolerability
  • Response of HIV RNA to TB treatment
  • Paradoxical reactions

Enrollment: 215
Study Start Date: February 1999
Study Completion Date: February 2003

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria

  • Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
  • Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
  • Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
  • > 18 years of age
  • Willingness to practice effective contraception if applicable
  • Signed informed consent

  • Exclusion Criteria
  • Pregnancy or breastfeeding
  • AST > 10 times the upper limit of normal
  • Bilirubin > 3.0 times the upper limit of normal
  • Creatinine > 3.0 times the upper limit of normal
  • Intolerance to any of the study drugs except isoniazid or pyrazinamide
  • Concomitant disorder that is contraindication to the use of the study drugs
  • More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
  • Bone/joint tuberculosis or silicotuberculosis

contacts and locations

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: NCT00023361

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
University of British Columbia
Vancouver, British Columbia, Canada, Canada V5Z 4R4
University of Manitoba
Winnipeg, Manitoba, Canada, CANADA R3A 1R8
Montreal Chest Institute McGill University
Montreal, Quebec, Canada, H2X 2P4Pq Canada

Sponsors and Collaborators

Centers for Disease Control and Prevention
VA Office of Research and Development

Investigators

Study Chair: William Burman, MD Denver Health and Hospitals
More Information

More Information

Additional Information:

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

Responsible Party: Centers for Disease Control and Prevention  
ClinicalTrials.gov Identifier: NCT00023361   History of Changes  
Other Study ID Numbers: CDC-NCHSTP-2174  
  TBTC STUDY 23  
Study First Received: September 6, 2001  
Last Updated: September 1, 2005  

Keywords provided by Centers for Disease Control and Prevention:

tuberculosis
TB

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Rifabutin

ClinicalTrials.gov processed this data on December 14, 2017
This information is provided by ClinicalTrials.gov.