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| Sponsored by: |
University of Zurich |
|---|---|
| Information provided by: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00537966 |
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-Term Observational Study |
| Estimated Enrollment: | 2016 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Control: No Intervention
Patients with primary HIV-1 infection who do not want to undergo early combination antiretroviral treatment
|
|
|
Intervention: Active Comparator
In this arm patients with primary HIV-1 infection will receive early combination antiretroviral therapy with standard drugs approved by Swiss Medic.
|
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)
Drug: atazanavir
standard dosage
Drug: efavirenz
standard dosage
Drug: fosamprenavir
standard dosage
Drug: darunavir
standard dosage
Drug: tipranavir
standard dosage
Drug: ritonavir
used only as booster for the protease inhibitors that are prescribed in this study according to standard boosting
Drug: nevirapine
standard dosage
Drug: zidovudine
standard dosage
Drug: lamivudine
standard dosage
Drug: tenofovir
standard dosage
Drug: emtricitabine
standard dosage
Drug: abacavir
standard dosage
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
A) Acute HIV-1 infection, defined as:
or
B) Recent HIV-1 infection, defined as:
Exclusion criteria:
Contacts and Locations| Contact: Huldrych Günthard, MD | +41 (0)44 255 11 11 | Huldrych.Guenthard@usz.ch |
| Switzerland | |
| University of Zurich | Recruiting |
| Zurich, Switzerland | |
| Contact: Huldrych. Günthard Huldrych.guenthard@usz.ch | |
| Principal Investigator: | Huldrych. Günthard, MD | UniversitaetsSpital Zuerich |
More Information
| Responsible Party: | University Hospital Zurich ( Huldrych Günthard, MD, Professor ) |
| Study ID Numbers: | INFZ-ZPHI-01.01 |
| Study First Received: | September 25, 2007 |
| Last Updated: | June 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00537966 |
| Health Authority: | Switzerland: Swissmedic |
|
Primary HIV Infection |
|
Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Atazanavir Immunologic Deficiency Syndromes Darunavir Tipranavir Virus Diseases Nevirapine |
Fosamprenavir Lopinavir Emtricitabine Ritonavir HIV Infections Sexually Transmitted Diseases Tenofovir Abacavir Retroviridae Infections Tenofovir disoproxil |
|
Antimetabolites Anti-Infective Agents Communicable Diseases HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |
