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Trial record 9 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study

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ClinicalTrials.gov Identifier: NCT00537966
Recruitment Status : Recruiting
First Posted : October 2, 2007
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Dolutegravir Drug: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate Drug: Raltegravir Drug: Darunavir Drug: Ritonavir Drug: Rilpivirine Drug: Lamivudine Drug: tenofovir Drug: Emtricitabine Drug: Abacavir Not Applicable

Detailed Description:
By the end of 2017 we have enrolled 450 patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2017 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study
Study Start Date : January 2002
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Drug: Dolutegravir
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: Tivicay

Drug: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate
standard dosage
Other Name: Genvoya

Drug: Raltegravir
standard dosage
Other Name: isentress

Drug: Darunavir
standard dosage
Other Name: Prezista

Drug: Ritonavir
used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
Other Name: Norvir

Drug: Rilpivirine
standard dosage
Other Name: Edurant

Drug: Lamivudine
standard dosage
Other Name: 3TC

Drug: tenofovir
standard dosage
Other Name: Viread

Drug: Emtricitabine
standard dosage
Other Name: Emtriva

Drug: Abacavir
standard dosage
Other Name: Ziagen




Primary Outcome Measures :
  1. To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

A) Acute HIV-1 infection, defined as:

  • Acute retroviral syndrome [78] (ARS) and negative or indeterminate Westernblot in the presence of a positive p24 Ag and/or detectable plasma HIV-1 RNA
  • Documented seroconversion with or without symptoms within 90 days.

or

B) Recent HIV-1 infection, defined as:

  • Possible ARS, positive Westernblot and detectable HIV-RNA, and a negative HIV-gp120 avidity [82, 83], respectively detuned assay [84].
  • Documented acute HIV-1 infection, however, referral to our center more than 90 days after presumed date of infection.

Exclusion criteria:

  • Hemoglobin < 10 g/dl (men) and < 9 g/dl (women) at the time of enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537966


Contacts
Contact: Huldrych Günthard, MD +41 (0)44 255 11 11 Huldrych.Guenthard@usz.ch

Locations
Switzerland
University of Zurich Recruiting
Zurich, Switzerland
Contact: Huldrych. Günthard       Huldrych.guenthard@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Huldrych. Günthard, MD UniversitaetsSpital Zuerich

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00537966     History of Changes
Other Study ID Numbers: INFZ-ZPHI-01.01
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by University of Zurich:
Primary HIV Infection

Additional relevant MeSH terms:
HIV Infections
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
Cobicistat
Tenofovir
Lamivudine
Raltegravir Potassium
Emtricitabine
Dolutegravir
Abacavir
Rilpivirine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors