An observational study in HIV Infection, sponsored by Clara Lehmann. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-13.
Sponsored by Clara Lehmann · Observational
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →This is the only study on the registry with Clara Lehmann as lead sponsor.
Counted across the registry records on this site, refreshed daily.
prospective longitudinal non- controlled phase IV study, 30 patients
Exclusion Criteria:
Procedure: colonoscopy with endoscopic biopsies
restoration of CD4 + T-cells in the GALT with ART
Time frame: 6 months
Function of Dendritic Cells (DC) in the GALT with ART
Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT
Time frame: 6 months
Functional characterization of NK-cells in the GALT with ART
Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART
Time frame: 6 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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