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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023361
First received: September 6, 2001
Last updated: September 1, 2005
Last verified: September 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
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

  Show 23 Study Locations
Sponsors and Collaborators
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
Study First Received: September 6, 2001
Last Updated: September 1, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tuberculosis
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
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
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014