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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

September 6, 2001
September 1, 2005
February 1999
Not Provided
Rate of confirmed treatment failure and relapse
Same as current
Complete list of historical versions of study NCT00023361 on ClinicalTrials.gov Archive Site
  • Safety and tolerability
  • Response of HIV RNA to TB treatment
  • Paradoxical reactions
Same as current
Not Provided
Not Provided
 
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

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).

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
Drug: Rifabutin
Not Provided
Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. Epub 2005 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
February 2003
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00023361
CDC-NCHSTP-2174, TBTC STUDY 23
Not Provided
Not Provided
Centers for Disease Control and Prevention
Department of Veterans Affairs
Study Chair: William Burman, MD Denver Health and Hospitals
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP