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NCT Number: NCT00537966

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich

Zurich, Switzerland

Location status: Recruiting

Location contact

Huldrych. Günthard

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A) 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).

B) 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 30 years

    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.

Secondary outcomes

  1. Systematic Collection and Analysis of Personal Health and Clinical Data

    Time frame: 30 Years

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

  2. Systematic Assessment of PHI to Identify Atypical Presentations

    Time frame: 30 Years

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

  3. Systematic Screening for Sexually Transmitted Infections (STIs)

    Time frame: 30 Years

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

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

    Time frame: 30 Years

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

  5. Investigation of Viral Factors in HIV-1 Pathogenesis

    Time frame: 30 Years

    • 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.

  6. Analysis of Biological Characteristics of Transmitted Viruses

    Time frame: 30 Years

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

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

    Time frame: 30 Years

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

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

    Time frame: 30 Years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Huldrych Günthard, MD

CONTACT

[email protected]

+41 (0)44 255 11 11

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: ZPHI

Important dates

Study start
2002
Primary completion
2028
Study completion
2028
First posted
Oct 2, 2007
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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