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OpenTrials
Completed

NCT Number: NCT00023361

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).

Completed

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Key information

Conditions

HIV Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rifabutin

Drug

Primary outcomes

  1. Rate of confirmed treatment failure and relapse

Secondary outcomes

  1. Safety and tolerability

  2. Response of HIV RNA to TB treatment

  3. Paradoxical reactions

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
1999
Study completion
2003
First posted
Sep 10, 2001
Registry last updated
Sep 5, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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