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

This study has been completed.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Department of Veterans Affairs
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00023361
  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

MedlinePlus related topics:   AIDS    Tuberculosis   

Drug Information available for:   Rifabutin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023361

Show 23 study locations  Show 23 Study Locations

Sponsors and Collaborators

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


(Click here for more information about the Tuberculosis Trials Consortium(TBTC)  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   CDC-NCHSTP-2174, TBTC STUDY 23
First Received:   September 6, 2001
Last Updated:   September 1, 2005
ClinicalTrials.gov Identifier:   NCT00023361
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Sexually Transmitted Diseases, Viral
Rifabutin
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Infection
Pharmacologic Actions
Actinomycetales Infections
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on December 03, 2008




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