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

Not Applicable

Completed

• Conditions: HIV-1-infection
• Interventions: Other: blood sample; Other: sperm sample

• Registration Number: NCT03075397
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV-1 infected patients	blood sample	Blood sample and sperm sample are collected
HIV-1 infected patients	sperm sample	Blood sample and sperm sample are collected

Primary Outcome Measures

Name	Time	Method
Evaluate the potential of seminal HIV infected cells migration and adhesion.	1 years	Assess the potential of seminal macrophages and CD4 T cells to adhere and transmigrate.
Characterize seminal HIV infected cells.	1 years	Macrophages and CD4+ T lymphocytes characterization.
Determine the efficiency of seminal cell associated infection.	1 years	The efficiency of seminal cell associated infection will be determinated in the colo-rectal explants.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CECOS Bretagne Rennes; 🇫🇷 Rennes, Bretagne, France

CECOS Hôpital Paule de Viguier; 🇫🇷 Toulouse, Midi-Pyrénées, France

CECOS Paris Bichat; 🇫🇷 Paris, France