Interaction Between HIV and Platelets

NCT04062825 | Unknown

• 1 other identifier: 19CCN-VIH-Plaquettes
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose that the lack of immune response in InR is driven by HIV-containing platelets that might interact with macrophages and CD4+ T-cells although by different mechanisms. In the one hand, HIV-sheltering platelets might fuel tissue HIV macrophage and in turn T cell reservoirs as observed in InRs and/or maintain a low-level viral replication in macrophages, sustaining a persistent inflammatory profile on in these cells. In the other hand,HIV-sheltering platelets might induce CD4+ T-cells dysfunctions via platelets/ectosomes, although without promoting platelet-to-T-cell HIV transfer/infection, thereby increasing the number of peripheral inflammatory TH17 cells and a TH17/Treg unbalance as observed in InRs. Main Objectives: i) To characterize and the molecular and functional level the platelet factors implicated in HIV transfer to tissue-like macrophages as well as in the immunomodulatory activity of HIV-containing platelets on macrophages and CD4+ T-cells. ii) To interrogate the transfer of HIV-containing platelet-derived mRNA and microRNA to tissue-like macrophages and CD4+ T-cells as one major mechanism of target cell immunomodulation. iii) To investigate the therapeutic potential of anti-platelet aggregation/activation agents (e.g. Abciximab), known to block platelet-immune cell interaction, in improving immune cell functions in vitro and promoting immunological recovery in vivo.

Conditions

HIV Seropositivity

Keywords

HIV; platelets; lymphocytes; cART; InRs

Outcome Measures

Primary Outcomes (2)

• CD4 number will be determined

  Immunological response status based on the presence-absence of HIV in platelets during follow-up: CD4 number will be determined by flow cytometry.

  at 48 month

• VIH level in platelet will be quantified

  Immunological response status based on the presence-absence of HIV in platelets during follow-up: VIH level in platelet will be quantified by flow fich and PCR.

  at 48 month

Secondary Outcomes (6)

• potential interaction between platelets and lymphocytes

  12-36 months

• potential interaction between platelets and lymphocytes

  12-36 months

• analyze if the interaction can be blocked by anti GPIIbIIIa

  12-36 months

• analyze if the interaction can be blocked by anti GPIIbIIIa

  12-36 months

• HIV expression on bone marrow smear

  1-48 months

Study Arms (3)

VIH positive patients without lymphoma

200 VIH positive patients without lymphoma

VIH positive patients with lymphoma

20 VIH positive patients with lymphoma

healthy volunteers

20 healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 VIH positive patients without lymphome + 20 VIH positive patients with lymphome + 20 healthy volunteers (VIH negative).

You may qualify if:

• For all patients:
• aged ⩾ 18 years;
• patients who can read and understand information document.
• For VIH positive patients without lymphoma:
• VIH positive patients with negative or positive viral load under cART since 1 year;
• patient under cART.
• For VIH positive patients with lymphoma:
• VIH positive patient with negative viral load under cART since 1 year;
• patient with lymphoma.
• For Healthy Volunteers:
• VIH negative patient (control) already included in clinical trial;
• patient major without haematological pathology.

You may not qualify if:

• patient \< 18 years;
• Unable to read and understand information document.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Service Hématologie Immunologie, Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Claude Capron, MD

  Service Hématologie Immunologie, Hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

• MORGANE BOMSEL, MD

  Unité CNRS UMR 8104, INSERM U1016, Laboratoire Entrée muqueuse du VIH et Immunité muqueuse, Département Infection, Immunité et Inflammation, Institut Cochin Université Paris Descartes

  STUDY DIRECTOR

Central Study Contacts

Claude Capron, MD

CONTACT

+33(0)149095847; claude.capron@aphp.fr

MORGANE BOMSEL, MD

CONTACT

+33(0)140516497; morgane.bomsel@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: August 20, 2019
• Study Start: April 17, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)