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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-Term Observational Study|
- To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: Control
Patients with primary HIV-1 infection who do not want to undergo early combination antiretroviral treatment
Active Comparator: Intervention
In this arm patients with primary HIV-1 infection will receive early combination antiretroviral therapy with standard drugs approved by Swiss Medic.
In this arm patients with primary HIV-1 infection are treated with standard antiretroviral combination therapy (only drugs that have been approved by Swiss Medic)
Other Name: KaletraDrug: atazanavir
Other Name: ReyatazDrug: efavirenz
Other Name: StocrinDrug: fosamprenavir
Other Name: TelzirDrug: darunavir
Other Name: PrezistaDrug: tipranavir
Other Name: AptivusDrug: ritonavir
used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
Other Name: NorvirDrug: nevirapine
Other Name: ViramuneDrug: zidovudine
Other Name: RetrovirDrug: lamivudine
Other Name: 3TCDrug: tenofovir
Other Name: VireadDrug: emtricitabine
Other Name: EmtrivaDrug: abacavir
Other Name: Ziagen
By the end of 2008, we have enrolled 200 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537966
|Contact: Huldrych Günthard, MD||+41 (0)44 255 11 11||Huldrych.Guenthard@usz.ch|
|University of Zurich||Recruiting|
|Contact: Huldrych. Günthard Huldrych.firstname.lastname@example.org|
|Principal Investigator:||Huldrych. Günthard, MD||UniversitaetsSpital Zuerich|