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Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679067
First Posted: September 5, 2012
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Clara Lehmann, University of Cologne
  Purpose
To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (Mussini C et al., 2008). These patients often present a real challenge due to their advanced clinical status (Borghi V et al., 2008). Unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the GALT.

Condition Intervention
HIV Infection Procedure: colonoscopy with endoscopic biopsies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)

Resource links provided by NLM:


Further study details as provided by Clara Lehmann, University of Cologne:

Primary Outcome Measures:
  • restoration of CD4 + T-cells in the GALT with ART [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Function of Dendritic Cells (DC) in the GALT with ART [ Time Frame: 6 months ]
    Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT

  • Functional characterization of NK-cells in the GALT with ART [ Time Frame: 6 months ]
    Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART


Biospecimen Retention:   Samples With DNA
Endoscopic biopsies, PBMC

Enrollment: 30
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-GALT Procedure: colonoscopy with endoscopic biopsies

Detailed Description:

The investigator proposes to evaluate the virological, immunological and clinical outcomes of ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and peripheral blood of HIV infected patients under ART. In particular the investigators want to longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by real-time PCR and correlate these data with laboratory and clinical parameters.

The investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under ART as well as understanding immunopathology during HIV-infection.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
prospective longitudinal non- controlled phase IV study, 30 patients
Criteria

Inclusion Criteria:

  • Documented HIV infection
  • Patients naive to antiretroviral treatment
  • Age older than 18 years
  • Indication for initiation of ART
  • Informed consent

Exclusion Criteria:

  • Patients on antiretroviral treatment
  • No informed consent
  • Estimated life expectancy <1 year
  • Age <18 years
  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): NCT01679067


Locations
Germany
University of Cologne
Cologne, Germany, 50937
Sponsors and Collaborators
Clara Lehmann
German Federal Ministry of Education and Research
  More Information

Responsible Party: Clara Lehmann, principal investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01679067     History of Changes
Other Study ID Numbers: GALT-HIV
First Submitted: August 31, 2012
First Posted: September 5, 2012
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Clara Lehmann, University of Cologne:
HIV
GALT

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases


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