Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients
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.
|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)|
- restoration of CD4 + T-cells in the GALT with ART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679067
|University of Cologne||Recruiting|
|Cologne, Germany, 50937|
|Contact: Clara Lehmann, MD +4922147888835 firstname.lastname@example.org|
|Principal Investigator: Lehmann Clara, MD|