Examination of B Cell Responses in Human Blood

This study has been completed.
Sponsor:
Collaborator:
University of Leipzig
Information provided by (Responsible Party):
Christian Jassoy, Regenerative Medicine Network
ClinicalTrials.gov Identifier:
NCT00806845
First received: December 10, 2008
Last updated: May 12, 2015
Last verified: May 2015
  Purpose

The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gewinnung Humaner antikörperproduzierender Zellen Aus Dem Blut

Resource links provided by NLM:


Further study details as provided by Regenerative Medicine Network:

Primary Outcome Measures:
  • Antigen specific B-cell responses [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

peripheral blood


Enrollment: 50
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV infected individuals, HIV controllers
CD4+ T cell count > 350/µl, HIV load < 1000 copies/ml
HIV infected individuals, early progressors
CD4+ T cell count > 350/µl, HIV load > 1000 copies/ml
HIV infected individuals, late progressors
CD4+ T cell count < 200/µl
HIV infected individuals, late progressors with therapy
CD4+ T cell count < 200/µl, under ART
Healthy individuals
Uninfected

Detailed Description:

Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV patients and controls attending specialised clinics, Germany

Criteria

Inclusion Criteria:

  • HIV-infected individuals
  • controls

Exclusion Criteria:

- none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806845

Locations
Germany
Universität Leipzig
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
Regenerative Medicine Network
University of Leipzig
Investigators
Study Director: Christian Jassoy, MD Universität Leipzig