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

Toulouse University Hospital

Status: Completed

Conditions: HIV-1-infection

Treatments: Other: blood sample; Other: sperm sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03075397

2016-A01025-46 (Other Identifier)

RC31/16/8193

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

HIV-1 infected patients

Other group

Description:

Blood sample and sperm sample are collected

Treatment:

Other: sperm sample

Other: blood sample