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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03075397
Acronym
CellspermVIH
Enrollment
15
Registered
2017-03-09
Start date
2017-02-27
Completion date
2021-06-14
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

Keywords

HIV-1, Colo-rectal transmission, seminal plasma

Brief summary

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

Detailed description

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.

Interventions

OTHERblood sample

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

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

Sponsors

ANRS, Emerging Infectious Diseases
CollaboratorOTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine the efficiency of seminal cell associated infection.1 yearsThe efficiency of seminal cell associated infection will be determinated in the colo-rectal explants.
Evaluate the potential of seminal HIV infected cells migration and adhesion.1 yearsAssess the potential of seminal macrophages and CD4 T cells to adhere and transmigrate.
Characterize seminal HIV infected cells.1 yearsMacrophages and CD4+ T lymphocytes characterization.

Secondary

MeasureTime frameDescription
Identify molecules expressed and involved in seminal cell adhesion and transmigration.1 yearsIdentify key adhesion molecules expressed by seminal leucocytes and epithelial cells involved in seminal cell adhesion/transmigration.
Identify seminal and mucosal molecules mediating seminal cell translocation.1 yearsSeminal and mucosal soluble molecules mediating seminal cell translocation will be characterized (passive diffusion or active transmigration).
Determine the impact of seminal plasma/cells exposure on mucosal immune cell.1 yearsMucosal immune cell activation, trafficking and the factors involved, will be evaluated.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026