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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Cologne.
Recruitment status was  Recruiting
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Clara Lehmann, University of Cologne Identifier:
First received: August 31, 2012
Last updated: September 6, 2012
Last verified: September 2012

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 University of Cologne:

Primary Outcome Measures:
  • restoration of CD4 + T-cells in the GALT with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function of Dendritic Cells (DC) in the GALT with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART

Biospecimen Retention:   Samples With DNA

Endoscopic biopsies, PBMC

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated 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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 identifier: NCT01679067

University of Cologne Recruiting
Cologne, Germany, 50937
Contact: Clara Lehmann, MD    +4922147888835   
Principal Investigator: Lehmann Clara, MD         
Sponsors and Collaborators
Clara Lehmann
German Federal Ministry of Education and Research
  More Information

Additional Information:
BMBF  This link exits the site

No publications provided

Responsible Party: Clara Lehmann, principal investigator, University of Cologne Identifier: NCT01679067     History of Changes
Other Study ID Numbers: GALT-HIV
Study First Received: August 31, 2012
Last Updated: September 6, 2012
Health Authority: Germany: Federal Ministry of Education and Research ':'

Keywords provided by University of Cologne:

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on March 03, 2015