Characterization of Acute and Recent HIV-1 Infections in Zurich. (ZPHI)

University of Zurich (UZH)

Status

Enrolling

Conditions

HIV Infections

Treatments

Drug: Abacavir

Drug: Lamivudine

Drug: Rilpivirine

Drug: Raltegravir

Drug: Dolutegravir

Drug: tenofovir

Drug: Ritonavir

Drug: Emtricitabine

Drug: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate

Drug: Darunavir

Study type

Observational

Funder types

Other

Identifiers

NCT00537966

INFZ-ZPHI-01.01

Details and patient eligibility

About

Aim of the study: To study and to describe factors which could influence the course of primary HIV infection (PHI) and factors that in turn could be influenced through PHI.

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.

Full description

The ZPHI is a longitudinal, observational, multi-center study. The ZPHI study started in 2002: The first patient visit (FPFV) was in January 2002. Since then, we continuously enrolled patients fulfilling the inclusion criteria. Because the ZPHI is an observational, longitudinal study and the HIV epidemic in Switzerland evolves continuously a clear study end point is not possible. We plan to critically revise the current protocol every 5 years and at that point, also evaluate whether the study should be continued.

This study so far has been highly successful in the recruitment of patients with a PHI. To date we have enrolled more than 480 patients with a documented PHI since project start in 2002.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A) acute HIV-1 infection, defined as:

negative or evolving immunoblot in the presence of positive p24 Ag and/or detectable plasma HIV-1 RNA and/or
documented HIV seroconversion within 90 dayswith or with-out symptoms and/or clinical signs of PHI (e.g. acute retro-viral syndrome).

B) recent HIV-1 infection, defined as:

documented seroconversion of more than 90 days but within 180 days and/or
evolving immunoblot after unambiguous transmission risk (e.g. iv drug use, sexual contact) within 180 days and/or
documented HIV infection and unambiguous transmission risk (iv drug use, sexual contact) within 180 days and/or
documented HIV infection and possible transmission risk (iv drug use, sexual contact) within the last 180 days after infection AND < 0.5% fraction of ambiguous nucleotides

Exclusion criteria

• Documented HIV infection, however, established diagnosis more than 180 days after presumed date of infection.