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NCT Number: NCT03075397

VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo (CellspermVIH)

The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants

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Key information

Conditions

HIV-1-infection

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CECOS Bretagne Rennes, Rennes, Brittany Region, France

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About this study

This project relies on:

  • our expertise of HIV in semen and male genital tract and our experience in organotypic cultures;
  • a network of infectious diseases and reproductive biology clinicians to collect, analyze and process seminal cells and seminal plasma from HIV+ donors;
  • the expertise in confocal microscopy and ex vivo colo-rectal model. State of the art culture of colo-rectal tissues, primary cell culture and infection, confocal microscopy, flow cytometry, Polymerase Chain Reaction and Luminex assays for cytokine measurements will be the methodologies primarily used in this project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-1 infected patients who have never been treated by antiretroviral therapy
  • Signature of informed consent
  • Affiliation to social service

Exclusion criteria

  • Patients' general condition not allowing protocol follow-up
  • Patients with an ejaculation disorder
  • Patients unable to perform semen sampling
  • Patients with chemotherapy or radiotherapy antecedents
  • Patients with very severe oligospermia (≤1million/mL of spermatozoa)
  • Patients with active genital infection
  • Protected subjects

Treatment and study plan

blood sample

Other

A sample of HIV-1 infected patients's blood is collected

sperm sample

Other

A sample of HIV-1 infected patients's sperm is collected

Primary outcomes

  1. Characterize seminal HIV infected cells.

    Time frame: 1 years

    Macrophages and CD4+ T lymphocytes characterization.

  2. Evaluate the potential of seminal HIV infected cells migration and adhesion.

    Time frame: 1 years

    Assess the potential of seminal macrophages and CD4 T cells to adhere and transmigrate.

  3. Determine the efficiency of seminal cell associated infection.

    Time frame: 1 years

    The efficiency of seminal cell associated infection will be determinated in the colo-rectal explants.

Secondary outcomes

  1. Identify molecules expressed and involved in seminal cell adhesion and transmigration.

    Time frame: 1 years

    Identify key adhesion molecules expressed by seminal leucocytes and epithelial cells involved in seminal cell adhesion/transmigration.

  2. Identify seminal and mucosal molecules mediating seminal cell translocation.

    Time frame: 1 years

    Seminal and mucosal soluble molecules mediating seminal cell translocation will be characterized (passive diffusion or active transmigration).

  3. Determine the impact of seminal plasma/cells exposure on mucosal immune cell.

    Time frame: 1 years

    Mucosal immune cell activation, trafficking and the factors involved, will be evaluated.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • ANRS, Emerging Infectious Diseases
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo

Acronym: CellspermVIH

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2017
Registry last updated
Mar 30, 2023

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

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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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