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

This study is currently recruiting participants.
Verified September 2007 by University of Zurich
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00537966
First received: September 25, 2007
Last updated: May 12, 2009
Last verified: September 2007

September 25, 2007
May 12, 2009
January 2002
December 2015   (final data collection date for primary outcome measure)
To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ] [ Designated as safety issue: No ]
To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ]
Complete list of historical versions of study NCT00537966 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-Term Observational Study
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 2008, we have enrolled 200 patients.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: lopinavir
    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: Kaletra
  • Drug: atazanavir
    standard dosage
    Other Name: Reyataz
  • Drug: efavirenz
    standard dosage
    Other Name: Stocrin
  • Drug: fosamprenavir
    standard dosage
    Other Name: Telzir
  • Drug: darunavir
    standard dosage
    Other Name: Prezista
  • Drug: tipranavir
    standard dosage
    Other Name: Aptivus
  • Drug: ritonavir
    used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
    Other Name: Norvir
  • Drug: nevirapine
    standard dosage
    Other Name: Viramune
  • Drug: zidovudine
    standard dosage
    Other Name: Retrovir
  • 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
  • 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: lopinavir
    • Drug: atazanavir
    • Drug: efavirenz
    • Drug: fosamprenavir
    • Drug: darunavir
    • Drug: tipranavir
    • Drug: ritonavir
    • Drug: nevirapine
    • Drug: zidovudine
    • Drug: lamivudine
    • Drug: tenofovir
    • Drug: emtricitabine
    • Drug: abacavir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2016
December 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Huldrych Günthard, MD +41 (0)44 255 11 11 Huldrych.Guenthard@usz.ch
Switzerland
 
NCT00537966
INFZ-ZPHI-01.01
No
Huldrych Günthard, MD, Professor, University Hospital Zurich
University of Zurich
Not Provided
Principal Investigator: Huldrych. Günthard, MD UniversitaetsSpital Zuerich
University of Zurich
September 2007

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