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Identification of Cytokine Profiles and T Cell Subsets Among Immunosuppressed Patients at Risk of Developing Active Tuberculosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Copenhagen Hospital Corporation
The Danish Rheumatism Association
The Danish Lung Association
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00285441
First received: January 31, 2006
Last updated: February 27, 2006
Last verified: December 2005
History of Changes
  Purpose

The purpose of this study is to identify differences in TB specific immune responses among immunosuppressed patients latently infected with TB and patients with active TB.


Condition
Tuberculosis
HIV Infections
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: September 2008
Detailed Description:

Immunosuppressed patients latently infected with TB are at higher risk of developing active TB than patients with normal immune functions. Especially two patient categories are at risk: HIV positives and patients receiving TNF-a blocking medication. Existing methods of diagnosis and surveillance of latent TB infection can not identify who will develop active TB and who can control the infection. There is a need for better understanding of TB specific immune functions,as we believe deficient TB specific immune reactions is a key in reactivation of latent TB infection.

In this study we follow groups of latent TB infected patients with either rheumatoid arthritis or HIV. We follow the patients during treatment with TNF-a blocking medication, HAART treatment or prophylactic TB medication. Results are correlated to patients with active TB, latent TB and healthy controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Latent TB infection + rheumatid arthritis
  • Latent TB infection + HIV
  • Active TB

Exclusion Criteria:

  • Age < 18yrs
  • Pregnancy
  • Patients not able to understand the given information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285441

Contacts
Contact: Morten Ruhwald, MD +45 36323632 mruhwald@mail.dk
Contact: Pernille Ravn, MD, Ph.d. +45 36323632 pravn@dadlnet.dk

Locations
Denmark
Infectious disease department University Hospital Hvidovre Recruiting
Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Copenhagen Hospital Corporation
The Danish Rheumatism Association
The Danish Lung Association
Investigators
Principal Investigator: Morten Ruhwald, MD University Hospital Hvidovre
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00285441     History of Changes
Other Study ID Numbers: KF-01-278477
Study First Received: January 31, 2006
Last Updated: February 27, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Arthritis
Arthritis, Rheumatoid
Tuberculosis
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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013