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

NCT03075397 | Completed

• 2 other identifiers: RC31/16/81932016-A01025-46
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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

Conditions

HIV-1-infection

Keywords

HIV-1; Colo-rectal transmission; seminal plasma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Identify molecules expressed and involved in seminal cell adhesion and transmigration.

  1 years

• Identify seminal and mucosal molecules mediating seminal cell translocation.

  1 years

• Determine the impact of seminal plasma/cells exposure on mucosal immune cell.

  1 years

Study Arms (1)

HIV-1 infected patients

OTHER

Blood sample and sperm sample are collected

Other: blood sample; Other: sperm sample

Interventions

blood sample OTHER

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

HIV-1 infected patients

sperm sample OTHER

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

HIV-1 infected patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-1 infected patients who have never been treated by antiretroviral therapy
• Signature of informed consent
• Affiliation to social service

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

CECOS Bretagne Rennes

Rennes, Brittany Region, 35200, France

Location

CECOS Hôpital Paule de Viguier

Toulouse, Midi-Pyrénées, 31059, France

Location

CECOS Paris Bichat

Paris, 75018, France

Location

Related Publications (6)

• 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.

  PMID: 17148672 BACKGROUND

• 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.

  PMID: 18347738 BACKGROUND

• 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.

  PMID: 19117522 BACKGROUND

• 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.

  PMID: 25414416 BACKGROUND

• 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.

  PMID: 26854806 BACKGROUND

• 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.

  PMID: 20010071 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nathalie Dejucq-Rainsford, PhD

  IRSET

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 9, 2017
• Study Start: February 27, 2017
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (3)