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

February 27, 2006 updated by: Hvidovre University Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pernille Ravn, MD, Ph.d.
  • Phone Number: +45 36323632
  • Email: pravn@dadlnet.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2650
        • Recruiting
        • Infectious disease department University Hospital Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Danish Lung Association
Copenhagen Hospital Corporation
The Danish Rheumatism Association

Investigators

  • Principal Investigator: Morten Ruhwald, MD, University Hospital Hvidovre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion

September 1, 2008

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2006

Last Update Submitted That Met QC Criteria

February 27, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-01-278477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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