HIV Infections Clinical Trial
Official title:
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study
Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of
early antiretroviral treatment and investigate early events of virus-host interactions in
patients with documented acute or recent HIV-1 infection in Zurich.
Study design: This is an open label, non-randomized, observational, single center study at
the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We
aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill
the inclusion criteria of a documented acute or recent HIV infection can participate in the
study. Patients are offered early combination antiretroviral treatment (cART), if treatment
start falls within 90 days after diagnosis of acute HIV-infection. After one year of
suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who
have not chosen to undergo early-cART, respectively will stop cART after one year will be
followed for a total of 5 years. Viral setpoints reached after treatment interruptions will
be compared to historic controls and to the control group not having received cART during
acute infection. A battery of virological and immunological assays will be performed on blood
samples obtained to better understand early virus-host interactions, which are thought to
play a key role in HIV-pathogenesis research.
Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection
with regard to epidemiology, impact of early-cART on the course of disease and forms the base
for a variety of translational research projects addressing early key pathogenesis events
between virus and host, relevant for the course of disease, for transmission, for development
of vaccines and new treatment strategies.
- Trial with medicinal product
By the end of 2017 we have enrolled 450 patients. ;
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