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

University Hospital, Toulouse15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

HIV-1-infection

Interventions

blood sampleOTHER

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

sperm sampleOTHER

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

CECOS Bretagne Rennes

Rennes, Brittany Region, France

CECOS Hôpital Paule de Viguier

Toulouse, Midi-Pyrénées, France

CECOS Paris Bichat

Paris, France

Outcomes

Primary Outcomes

Characterize seminal HIV infected cells.

Macrophages and CD4+ T lymphocytes characterization.

Time frame: 1 years

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

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

Time frame: 1 years

Determine the efficiency of seminal cell associated infection.

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

Time frame: 1 years

Secondary Outcomes

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

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

Time frame: 1 years

Identify seminal and mucosal molecules mediating seminal cell translocation.

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

Time frame: 1 years

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

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

Time frame: 1 years

Data from ClinicalTrials.gov

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