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

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ClinicalTrials.gov Identifier: NCT00285441
Recruitment Status : Unknown
Verified December 2005 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2006
Last Update Posted : February 28, 2006
Sponsor:
Collaborators:
Copenhagen Hospital Corporation
The Danish Rheumatism Association
Danish Lung Association
Information provided by:
Hvidovre University Hospital

Study Description
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Brief Summary:
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 or disease
Tuberculosis HIV Infections Rheumatoid Arthritis

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.

Study Design
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Study Type : Observational
Enrollment : 60 participants
Observational Model: Defined Population
Time Perspective: Prospective
Study Start Date : November 2005
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285441


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

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

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ClinicalTrials.gov Identifier: NCT00285441    
Other Study ID Numbers: KF-01-278477
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 28, 2006
Last Verified: December 2005
Keywords provided by Hvidovre University Hospital:
HIV
Additional relevant MeSH terms:
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Tuberculosis
Infections
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses