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

NCT ID: NCT00285441

Last Updated: 2006-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tuberculosis HIV Infections Rheumatoid Arthritis

Keywords

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HIV

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen Hospital Corporation

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Danish Lung Association

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Morten Ruhwald, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hvidovre

Locations

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Infectious disease department University Hospital Hvidovre

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Ruhwald, MD

Role: CONTACT

Phone: +45 36323632

Email: [email protected]

Pernille Ravn, MD, Ph.d.

Role: CONTACT

Phone: +45 36323632

Email: [email protected]

Related Links

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http://www.hvidovrehospital.dk

Related Info

Other Identifiers

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KF-01-278477

Identifier Type: -

Identifier Source: org_study_id