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

This study has been completed.

First Received: September 6, 2001 Last Updated: September 1, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Rifabutin

U.S. FDA Resources

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

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators

Study Chair:

William Burman, MD

Denver Health and Hospitals

More Information

Additional Information:

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

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.

Study ID Numbers:	CDC-NCHSTP-2174, TBTC STUDY 23
Study First Received:	September 6, 2001
Last Updated:	September 1, 2005
ClinicalTrials.gov Identifier:	NCT00023361 History of Changes
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
Sexually Transmitted Diseases, Viral
Rifabutin
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents

Gram-Positive Bacterial Infections
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Tuberculosis
Antitubercular Agents
Retroviridae Infections

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Rifabutin
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Actinomycetales Infections
Immunologic Deficiency Syndromes

Antibiotics, Antitubercular
Virus Diseases
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Tuberculosis
Antitubercular Agents
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009