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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: blood sample
* Other: sperm sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV-1 infected patients<br>Blood sample and sperm sample are collected | Other: blood sample<br>* A sample of HIV-1 infected patients's blood is collected<br>Other: sperm sample<br>* A sample of HIV-1 infected patients's sperm is collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize seminal HIV infected cells. | Macrophages and CD4+ T lymphocytes characterization. | 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. | 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. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, Colo-rectal transmission, seminal plasma