HIV Infection Clinical Trial
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)
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.
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Observational Model: Cohort, Time Perspective: Prospective
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