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HIV InfectionsZPHINCT00537966

Characterization of Acute and Recent HIV-1 Infections in Zurich.

An observational study of HIV Infections, run by University of Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Aim of the study: To study and to describe factors which could influence the course of primary HIV infection (PHI) and factors that in turn could be influenced through PHI. In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
How many people
800 participants
Where
1 siteSwitzerland
Study dates
Jan 2002to Dec 2028
How long will I take part?
30 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Men and women > 18 years with a documented acute or recent HIV-1 infection.

Who may be able to join

  • acute HIV-1 infection, defined as:
  • negative or evolving immunoblot in the presence of positive p24 Ag and/or detectable plasma HIV-1 RNA and/or
  • documented HIV seroconversion within 90 dayswith or with-out symptoms and/or clinical signs of PHI (e.g. acute retro-viral syndrome).
  • recent HIV-1 infection, defined as:
  • documented seroconversion of more than 90 days but within 180 days and/or
  • evolving immunoblot after unambiguous transmission risk (e.g. iv drug use, sexual contact) within 180 days and/or
  • documented HIV infection and unambiguous transmission risk (iv drug use, sexual contact) within 180 days and/or
  • documented HIV infection and possible transmission risk (iv drug use, sexual contact) within the last 180 days after infection AND < 0.5% fraction of ambiguous nucleotides

Who cannot join

  • Documented HIV infection, however, established diagnosis more than 180 days after presumed date of infection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huldrych Günthard, MD contact

+41 (0)44 255 11 11

Huldrych.Guenthard@usz.ch

Switzerland1 site, 1 recruiting
  • University of Zurich

    Zurich

    Huldrych. Günthard, Huldrych.guenthard@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Characterization of Acute and Recent HIV-1 Infections in Zurich. a Long-term Observational Study: the Zurich Primary HIV Infection Study.

Aim of the study: To study and to describe factors which could influence the course of primary HIV infection (PHI) and factors that in turn could be influenced through PHI.

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.

Read the detailed description

The ZPHI is a longitudinal, observational, multi-center study. The ZPHI study started in 2002: The first patient visit (FPFV) was in January 2002. Since then, we continuously enrolled patients fulfilling the inclusion criteria. Because the ZPHI is an observational, longitudinal study and the HIV epidemic in Switzerland evolves continuously a clear study end point is not possible. We plan to critically revise the current protocol every 5 years and at that point, also evaluate whether the study should be continued.

This study so far has been highly successful in the recruitment of patients with a PHI. To date we have enrolled more than 480 patients with a documented PHI since project start in 2002.

Conditions
HIV Infections
Keywords
Primary HIV Infection
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00537966
Study groupRoleWhat they receive
Primo - CohortThe patients with primary HIV-1 infection will receive combination antiretroviral therapy with standard drugs approved by Swiss Medic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of early events between virus and host to better understand HIV-pathogenesis during the early course of HIV infection.

    The enrolment and the longitudinal follow up of patients with a documented PHI will allow us to study early events between virus and host and to better understand HIV-pathogenesis during the early course of HIV infection.

    We aim to expand the established biobank in order to collect samples from patients with an acute or recent HIV infection: For the biobank, we will collect blood samples which are obtained in addition to the routinely collected clinical samples. This concerns ETDA blood samples, initially collected every 3 months until week 48, followed by every six months until week 240 and thereafter once yearly from week 240 onwards. Moreover, a stool sample will be collected and stored for research purposes only. In addition, we will store routinely collected CSF, STI swabs (rectal, virginal, urethral, pharyngeal), urethral swabs, stool samples and in case of high-resolution anoscopy also rectal biopsy materialin the biobanks of the accoding institutes.

    Measured: 30 years

Secondary outcomes (8)
  1. Systematic Collection and Analysis of Personal Health and Clinical Data

    • Secondary Outcome: Number of participants with complete health and clinical datasets analyzed.
    • Unit of Measure: Count of datasets.

    Measured: 30 Years

  2. Systematic Assessment of PHI to Identify Atypical Presentations

    • Secondary Outcome: Percentage of participants presenting atypical symptoms of PHI.
    • Unit of Measure: Percentage.

    Measured: 30 Years

  3. Systematic Screening for Sexually Transmitted Infections (STIs)

    • Secondary Outcome: Number of STI cases identified, classified by clinical characteristics and resistance patterns.
    • Unit of Measure: Count of cases

    Measured: 30 Years

  4. Identification of Transmission Networks for HIV and Acute Hepatitis C

    • Secondary Outcome: Number of transmission clusters identified through phylogenetic analysis.
    • Unit of Measure: Count of clusters.

    Measured: 30 Years

  5. Investigation of Viral Factors in HIV-1 Pathogenesis

    • Secondary Outcome: Percentage of patient samples with drug-resistant variants, viral diversity, or replication capacity metrics.
    • Unit of Measure: Percentage or specific diversity/replication scores.

    Measured: 30 Years

  6. Analysis of Biological Characteristics of Transmitted Viruses

    • Secondary Outcome: Replication capacity of transmitted viruses
    • Unit of Measure: Replication cycles/hour

    Measured: 30 Years

  7. Study of HIV-Specific Immune Responses and Innate Immune System Factors

    • Secondary Outcome: Concentration of immune markers, such as cytokine levels, associated with specific immune responses.
    • Unit of Measure: Concentration (pg/mL).

    Measured: 30 Years

  8. Genetic Studies Using Next-Generation Sequencing to Investigate Traits Linked to HIV Progression

    • Secondary Outcome: Number of genetic polymorphisms associated with differential progression in natural HIV infection.
    • Unit of Measure: Count of identified polymorphisms.

    Measured: 30 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2007 (estimated)
  2. Study startJan 2002
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT00537966
Sponsor's protocol ID
INFZ-ZPHI-01.01
Acronym
ZPHI
Status last verified
Dec 2024
First submitted
25 Sep 2007
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rusert P, Kuster H, Joos B, Misselwitz B, Gujer C, Leemann C, Fischer M, Stiegler G, Katinger H, Olson WC, Weber R, Aceto L, Gunthard HF, Trkola A. Virus isolates during acute and chronic human immunodeficiency virus type 1 infection show distinct patterns of sensitivity to entry inhibitors. J Virol. 2005 Jul;79(13):8454-69. doi: 10.1128/JVI.79.13.8454-8469.2005.

    PubMed 15956589
  • Joos B, Trkola A, Fischer M, Kuster H, Rusert P, Leemann C, Boni J, Oxenius A, Price DA, Phillips RE, Wong JK, Hirschel B, Weber R, Gunthard HF; Swiss HIV Cohort Study. Low human immunodeficiency virus envelope diversity correlates with low in vitro replication capacity and predicts spontaneous control of plasma viremia after treatment interruptions. J Virol. 2005 Jul;79(14):9026-37. doi: 10.1128/JVI.79.14.9026-9037.2005.

    PubMed 15994796
  • Aceto L, Karrer U, Grube Ch, Oberholzer R, Hasse B, Presterl E, Boni J, Kuster H, Trkola A, Weber R, Gunthard HF. [Primary HIV-1 infection in Zurich: 2002-2004]. Praxis (Bern 1994). 2005 Aug 10;94(32):1199-205. doi: 10.1024/0369-8394.94.32.1199. German.

    PubMed 16128207
  • Joos B, Trkola A, Kuster H, Aceto L, Fischer M, Stiegler G, Armbruster C, Vcelar B, Katinger H, Gunthard HF. Long-term multiple-dose pharmacokinetics of human monoclonal antibodies (MAbs) against human immunodeficiency virus type 1 envelope gp120 (MAb 2G12) and gp41 (MAbs 4E10 and 2F5). Antimicrob Agents Chemother. 2006 May;50(5):1773-9. doi: 10.1128/AAC.50.5.1773-1779.2006.

    PubMed 16641449
  • Huber M, Fischer M, Misselwitz B, Manrique A, Kuster H, Niederost B, Weber R, von Wyl V, Gunthard HF, Trkola A. Complement lysis activity in autologous plasma is associated with lower viral loads during the acute phase of HIV-1 infection. PLoS Med. 2006 Nov;3(11):e441. doi: 10.1371/journal.pmed.0030441.

    PubMed 17121450
  • Manrique A, Rusert P, Joos B, Fischer M, Kuster H, Leemann C, Niederost B, Weber R, Stiegler G, Katinger H, Gunthard HF, Trkola A. In vivo and in vitro escape from neutralizing antibodies 2G12, 2F5, and 4E10. J Virol. 2007 Aug;81(16):8793-808. doi: 10.1128/JVI.00598-07. Epub 2007 Jun 13.

    PubMed 17567707
  • Trkola A, Kuster H, Rusert P, von Wyl V, Leemann C, Weber R, Stiegler G, Katinger H, Joos B, Gunthard HF. In vivo efficacy of human immunodeficiency virus neutralizing antibodies: estimates for protective titers. J Virol. 2008 Feb;82(3):1591-9. doi: 10.1128/JVI.01792-07. Epub 2007 Nov 21.

    PubMed 18032508
  • Huber M, von Wyl V, Ammann CG, Kuster H, Stiegler G, Katinger H, Weber R, Fischer M, Stoiber H, Gunthard HF, Trkola A. Potent human immunodeficiency virus-neutralizing and complement lysis activities of antibodies are not obligatorily linked. J Virol. 2008 Apr;82(8):3834-42. doi: 10.1128/JVI.02569-07. Epub 2008 Jan 30.

    PubMed 18234794
  • Gianella S, Yu T, Wang R, Ignacio C, Schanz M, Kouyos RD, Caballero G, Gaitan NC, Rawlings S, Kuster H, Metzner KJ, Gandhi RT, Li JZ, Gunthard HF, Smith DM, Chaillon A. Viral and Immune Risk Factors of HIV Rebound After Interruption of Antiretroviral Therapy. J Infect Dis. 2025 Jun 2;231(5):1221-1229. doi: 10.1093/infdis/jiae585.

    PubMed 39661441
  • Ring A, Balakrishna S, Imkamp F, Burkard S, Triet F, Brunschweiler F, Grube C, Bodmer R, Kouyos RD, Gunthard HF, Braun DL. High Rates of Asymptomatic Mycoplasma genitalium Infections With High Proportion of Genotypic Resistance to First-Line Macrolide Treatment Among Men Who Have Sex With Men Enrolled in the Zurich Primary HIV Infection Study. Open Forum Infect Dis. 2022 Apr 27;9(6):ofac217. doi: 10.1093/ofid/ofac217. eCollection 2022 Jun.

    PubMed 35783686
  • Rindler AE, Kusejko K, Kuster H, Neumann K, Leemann C, Zeeb M, Chaudron SE, Braun DL, Kouyos RD, Metzner KJ, Gunthard HF. The Interplay Between Replication Capacity of HIV-1 and Surrogate Markers of Disease. J Infect Dis. 2022 Sep 21;226(6):1057-1068. doi: 10.1093/infdis/jiac100.

    PubMed 35299248
  • Braun DL, Marzel A, Steffens D, Schreiber PW, Grube C, Scherrer AU, Kouyos RD, Gunthard HF; Swiss HIV Cohort Study. High Rates of Subsequent Asymptomatic Sexually Transmitted Infections and Risky Sexual Behavior in Patients Initially Presenting With Primary Human Immunodeficiency Virus-1 Infection. Clin Infect Dis. 2018 Feb 10;66(5):735-742. doi: 10.1093/cid/cix873.

    PubMed 29028966
  • Bastidas S, Graw F, Smith MZ, Kuster H, Gunthard HF, Oxenius A. CD8+ T cells are activated in an antigen-independent manner in HIV-infected individuals. J Immunol. 2014 Feb 15;192(4):1732-44. doi: 10.4049/jimmunol.1302027. Epub 2014 Jan 20.

    PubMed 24446519
  • Metzner KJ, Leemann C, Di Giallonardo F, Grube C, Scherrer AU, Braun D, Kuster H, Weber R, Guenthard HF. Reappearance of minority K103N HIV-1 variants after interruption of ART initiated during primary HIV-1 infection. PLoS One. 2011;6(7):e21734. doi: 10.1371/journal.pone.0021734. Epub 2011 Jul 6.

    PubMed 21754996

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huldrych Günthard, MD (+41 (0)44 255 11 11, Huldrych.Guenthard@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of early events between virus and host to better understand HIV-pathogenesis during the early course of HIV infection. (time frame: 30 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537966, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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