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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00023361
First Posted: September 10, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Office of Research and Development
Information provided by:
Centers for Disease Control and Prevention
  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

Resource links provided by NLM:


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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023361


  Show 23 Study Locations
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00023361     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2174
TBTC STUDY 23
First Submitted: September 6, 2001
First Posted: September 10, 2001
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents