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

NCT ID: NCT03075397

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2021-06-14

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.

Conditions

HIV-1-infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

HIV-1 infected patients

Blood sample and sperm sample are collected

Group Type: OTHER

blood sample

Intervention Type: OTHER

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

sperm sample

Intervention Type: OTHER

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

Interventions

blood sample

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

Intervention Type: OTHER

sperm sample

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie Dejucq-Rainsford, PhD

Role: STUDY_DIRECTOR

IRSET

Locations

CECOS Bretagne Rennes

Rennes, Brittany Region, France

CECOS Hôpital Paule de Viguier

Toulouse, Midi-Pyrénées, France

CECOS Paris Bichat

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 17148672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18347738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19117522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25414416 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26854806 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20010071 (View on PubMed)

Other Identifiers

2016-A01025-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/16/8193

Identifier Type: -

Identifier Source: org_study_id