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

This study is currently recruiting participants.

Verified September 2012 by University of Cologne

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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2012
Last Updated Date	September 6, 2012
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2012)	restoration of CD4 + T-cells in the GALT with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01679067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 6, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: August 31, 2012)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients
Official Title ^ICMJE	Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Endoscopic biopsies, PBMC
Sampling Method	Non-Probability Sample
Study Population	prospective longitudinal non- controlled phase IV study, 30 patients
Condition ^ICMJE	HIV Infection
Intervention ^ICMJE	Procedure: colonoscopy with endoscopic biopsies
Study Group/Cohort (s)	HIV-GALT Intervention: Procedure: colonoscopy with endoscopic biopsies
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01679067
Other Study ID Numbers ^ICMJE	GALT-HIV
Has Data Monitoring Committee	No
Responsible Party	Clara Lehmann, University of Cologne
Study Sponsor ^ICMJE	Clara Lehmann
Collaborators ^ICMJE	German Federal Ministry of Education and Research
Investigators ^ICMJE	Not Provided
Information Provided By	University of Cologne
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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