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

HIV-1-infection Clinical Trial

— CellspermVIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075397
• Other study ID #: RC31/16/8193
• Secondary ID: 2016-A01025-46
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: June 14, 2021

Study information

• Verified date: March 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Other:
• blood sample
A sample of HIV-1 infected patients's blood is collected
• sperm sample
A sample of HIV-1 infected patients's sperm is collected

Locations

Country	Name	City	State
France	CECOS Paris Bichat	Paris
France	CECOS Bretagne Rennes	Rennes	Bretagne
France	CECOS Hôpital Paule de Viguier	Toulouse	Midi-Pyrénées

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	ANRS, Emerging Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (6)

Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH. Targeting Trojan Horse leukocytes for HIV prevention. AIDS. 2010 Jan 16;24(2):163-87. doi: 10.1097/QAD.0b013e32833424c8. No abstract available. — View Citation

Camus C, Matusali G, Bourry O, Mahe D, Aubry F, Bujan L, Pasquier C, Massip P, Ravel C, Zirafi O, Munch J, Roan NR, Pineau C, Dejucq-Rainsford N. Comparison of the effect of semen from HIV-infected and uninfected men on CD4+ T-cell infection. AIDS. 2016 May 15;30(8):1197-208. doi: 10.1097/QAD.0000000000001048. — View Citation

Houzet L, Matusali G, Dejucq-Rainsford N. Origins of HIV-infected leukocytes and virions in semen. J Infect Dis. 2014 Dec 15;210 Suppl 3:S622-30. doi: 10.1093/infdis/jiu328. — View Citation

Le Tortorec A, Le Grand R, Denis H, Satie AP, Mannioui K, Roques P, Maillard A, Daniels S, Jegou B, Dejucq-Rainsford N. Infection of semen-producing organs by SIV during the acute and chronic stages of the disease. PLoS One. 2008 Mar 12;3(3):e1792. doi: 10.1371/journal.pone.0001792. — View Citation

Le Tortorec A, Satie AP, Denis H, Rioux-Leclercq N, Havard L, Ruffault A, Jegou B, Dejucq-Rainsford N. Human prostate supports more efficient replication of HIV-1 R5 than X4 strains ex vivo. Retrovirology. 2008 Dec 31;5:119. doi: 10.1186/1742-4690-5-119. — View Citation

Roulet V, Satie AP, Ruffault A, Le Tortorec A, Denis H, Guist'hau O, Patard JJ, Rioux-Leclerq N, Gicquel J, Jegou B, Dejucq-Rainsford N. Susceptibility of human testis to human immunodeficiency virus-1 infection in situ and in vitro. Am J Pathol. 2006 Dec;169(6):2094-103. doi: 10.2353/ajpath.2006.060191. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize seminal HIV infected cells.	Macrophages and CD4+ T lymphocytes characterization.	1 years
Primary	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
Primary	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	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
Secondary	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
Secondary	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