HIV-1-infectionCellspermVIHNCT03075397
VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo (CellspermVIH)
A study testing blood sample and sperm sample in people with HIV-1-infection, run by University Hospital, Toulouse at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- blood sample and sperm sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Feb 2017to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- HIV-1 infected patients who have never been treated by antiretroviral therapy
- Signature of informed consent
- Affiliation to social service
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
CECOS Paris Bichat
Paris, 75018
CECOS Bretagne Rennes
Rennes, Brittany Region, 35200
CECOS Hôpital Paule de Viguier
Toulouse, Midi-Pyrénées, 31059
About this study
Official title: VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo
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
Read the 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
- Being tested
- blood sample, sperm sample
- Keywords
- HIV-1, Colo-rectal transmission, seminal plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
A sample of HIV-1 infected patients's blood is collected
sperm sampleOther
A sample of HIV-1 infected patients's sperm is collected
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 infected patients | Other | Blood sample and sperm sample are collected Receives: Other: blood sample; Other: sperm sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize seminal HIV infected cells.
Macrophages and CD4+ T lymphocytes characterization.
Measured: 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.
Measured: 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.
Measured: 1 years
Secondary outcomes (3)
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.
Measured: 1 years
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).
Measured: 1 years
Determine the impact of seminal plasma/cells exposure on mucosal immune cell.
Mucosal immune cell activation, trafficking and the factors involved, will be evaluated.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start27 Feb 2017
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Nathalie Dejucq-Rainsford, PhD, Study director, IRSET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075397
- Sponsor's protocol ID
- RC31/16/8193
- Other IDs
- 2016-A01025-46
- Acronym
- CellspermVIH
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The duplicated part of the CRFs will then be sent to Mrs DEJUC at the IRST in Rennes, the remaining part will be kept in the investigating center. All the data of the study transcribed by the investigator in the CRFs will be transmitted electronically to the person in charge of the data of the INSERM / IRSET 1085 unit. Upon receipt, the data will be entered simply by typing and re-reading on the Excel spreadsheet. The files will be locked by password and backed up daily with storage for 3 months on the server of the INSERM 1085 unit managed by the IT department of the University of Rennes 1. The set Data is saved every evening, with storage for 4 weeks, then archived monthly on tape.
Publications
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.
PubMed 17148672Le 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.
PubMed 18347738Le 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.
PubMed 19117522Houzet 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.
PubMed 25414416Camus 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.
PubMed 26854806Anderson 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.
PubMed 20010071
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo
- ClinicalTrials.gov ID
- NCT03075397
- Acronym / sponsor ID
- CellspermVIH / RC31/16/8193
- Conditions
- HIV-1-infection
- Keywords
- HIV-1, Colo-rectal transmission, seminal plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 infected patients | Other | Other: blood sample, Other: sperm sampleBlood sample and sperm sample are collected |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV-1 infected patients who have never been treated by antiretroviral therapy
- Signature of informed consent
- Affiliation to social service
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleA sample of HIV-1 infected patients's blood is collected | Other | HIV-1 infected patients |
| sperm sampleA sample of HIV-1 infected patients's sperm is collected | Other | HIV-1 infected patients |
Primary outcome
Characterize seminal HIV infected cells.
Time frame: 1 years
Macrophages and CD4+ T lymphocytes characterization.
Evaluate the potential of seminal HIV infected cells migration and adhesion.
Time frame: 1 years
Assess the potential of seminal macrophages and CD4 T cells to adhere and transmigrate.
Determine the efficiency of seminal cell associated infection.
Time frame: 1 years
The efficiency of seminal cell associated infection will be determinated in the colo-rectal explants.
3 secondary outcomes
Identify molecules expressed and involved in seminal cell adhesion and transmigration.
Time frame: 1 years
Identify seminal and mucosal molecules mediating seminal cell translocation.
Time frame: 1 years
Determine the impact of seminal plasma/cells exposure on mucosal immune cell.
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 17148672Roulet 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.
- Background: PubMed 18347738Le 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.
- Background: PubMed 19117522Le 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.
- Background: PubMed 25414416Houzet 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.
- Background: PubMed 26854806Camus 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.
- Background: PubMed 20010071Anderson 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.
- Individual participant dataSharing planned: Yes. The duplicated part of the CRFs will then be sent to Mrs DEJUC at the IRST in Rennes, the remaining part will be kept in the investigating center. All the data of the study transcribed by the investigator in the CRFs will be transmitted electronically to the person in charge of the data of the INSERM / IRSET 1085 unit. Upon receipt, the data will be entered simply by typing and re-reading on the Excel spreadsheet. The files will be locked by password and backed up daily with storage for 3 months on the server of the INSERM 1085 unit managed by the IT department of the University of Rennes 1. The set Data is saved every evening, with storage for 4 weeks, then archived monthly on tape.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Dejucq-Rainsford, PhD study director
IRSET
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and sperm sample in people with HIV-1-infection, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize seminal HIV infected cells. (time frame: 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075397, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.