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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00537966
First received: September 25, 2007
Last updated: November 3, 2016
Last verified: November 2016
  Purpose

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 Intervention
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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • To evaluate the effect of early-cART on the viral setpoint [ Time Frame: 2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2016
Study Start Date: January 2002
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
By the end of 2008, we have enrolled 200 patients.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: September 25, 2007
Last Updated: November 3, 2016
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Primary HIV Infection

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

ClinicalTrials.gov processed this record on December 09, 2016