VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo (CellspermVIH)
- Conditions
- HIV-1-infection
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- HIV-1 infected patients who have never been treated by antiretroviral therapy
- Signature of informed consent
- Affiliation to social service
- 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
- 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
CECOS Bretagne Rennes🇫🇷Rennes, Bretagne, France