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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:
Information provided by:

Study Description
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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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
Danish Lung Association
Investigators
Principal Investigator: Morten Ruhwald, MD University Hospital Hvidovre
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00285441     History of Changes
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:
Arthritis, Rheumatoid
HIV Infections
Tuberculosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections