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

Tracking Information

First Received Date ^ICMJE

September 6, 2001

Last Updated Date

September 1, 2005

Start Date ^ICMJE

February 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Rate of confirmed treatment failure and relapse

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00023361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections
Tuberculosis

Intervention ^ICMJE

Drug: Rifabutin

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

215

Completion Date

February 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00023361

Responsible Party

Study ID Numbers ^ICMJE

CDC-NCHSTP-2174, TBTC STUDY 23

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Department of Veterans Affairs

Investigators ^ICMJE

Study Chair:

William Burman, MD

Denver Health and Hospitals

Information Provided By

Centers for Disease Control and Prevention

Verification Date

September 2005

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