Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE September 25, 2007
First Posted Date  ICMJE October 2, 2007
Last Update Posted Date November 8, 2017
Study Start Date  ICMJE January 2002
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2007)
To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00537966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study
Official Title  ICMJE Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study
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
Detailed Description By the end of 2017 we have enrolled 450 patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2017)
2017
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2007)
2016
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huldrych Günthard, MD +41 (0)44 255 11 11 Huldrych.Guenthard@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537966
Other Study ID Numbers  ICMJE INFZ-ZPHI-01.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huldrych. Günthard, MD UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP