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

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ClinicalTrials.gov Identifier: NCT01679067
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infection 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.

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
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)
Study Start Date : June 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
HIV-GALT Procedure: colonoscopy with endoscopic biopsies

Outcome Measures

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

Secondary Outcome Measures :
  1. 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

  2. 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

Eligibility Criteria

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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

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

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 Posted: September 5, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Clara Lehmann, University of Cologne:

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