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
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Clara Lehmann, University of Cologne
ClinicalTrials.gov Identifier:
NCT01679067
First received: August 31, 2012
Last updated: September 6, 2012
Last verified: September 2012

August 31, 2012
September 6, 2012
June 2011
June 2013   (final data collection date for primary outcome measure)
restoration of CD4 + T-cells in the GALT with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01679067 on ClinicalTrials.gov Archive Site
  • 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
DCs, NK-cells, as well as the levels of IFNγ, IFNα, TNFα, and IL-12 with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients
Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Endoscopic biopsies, PBMC

Non-Probability Sample

prospective longitudinal non- controlled phase IV study, 30 patients

HIV Infection
Procedure: colonoscopy with endoscopic biopsies
HIV-GALT
Intervention: Procedure: colonoscopy with endoscopic biopsies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Germany
 
NCT01679067
GALT-HIV
No
Clara Lehmann, University of Cologne
Clara Lehmann
German Federal Ministry of Education and Research
Not Provided
University of Cologne
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP