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Interaction Between HIV and Platelets (PLAQUEVIH)

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ClinicalTrials.gov Identifier: NCT04062825
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
HIV Seropositivity

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interaction of HIV/Platelets and HIV-platelets/Lymphocytes in HIV Patients Under cART Treatment But Immunological Non Responders
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. CD4 number will be determined [ Time Frame: at 48 month ]
    Immunological response status based on the presence-absence of HIV in platelets during follow-up: CD4 number will be determined by flow cytometry.

  2. VIH level in platelet will be quantified [ Time Frame: at 48 month ]
    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.


Secondary Outcome Measures :
  1. potential interaction between platelets and lymphocytes [ Time Frame: 12-36 months ]
    in vitro characterization of interaction between lymphocytes and platelets by microscopy. The cells will be stained with specific antibodies

  2. potential interaction between platelets and lymphocytes [ Time Frame: 12-36 months ]
    in vitro characterization of interaction between lymphocytes and platelets by flow cytometry. The cells will be stained with specific antibodies

  3. analyze if the interaction can be blocked by anti GPIIbIIIa [ Time Frame: 12-36 months ]
    anti GPIIbIIIa will be added in culture dish with platelets and lymphocytes. Analysis of inhibition of interaction will be performed by flow cytometry.

  4. analyze if the interaction can be blocked by anti GPIIbIIIa [ Time Frame: 12-36 months ]
    anti GPIIbIIIa will be added in culture dish with platelets and lymphocytes. Analysis of inhibition of interaction will be performed by microscopy.

  5. HIV expression on bone marrow smear [ Time Frame: 1-48 months ]
    cells from bone marrow will be spread on a slide; and presence of HIV will be performed with an anti HIV anti body

  6. soluble factors secretion [ Time Frame: 12-36 months ]
    HIV+ platelets will be cultivated with donor's CD4 lymphocytes of. By ELISA and/or Bioplex, the secretion of soluble factors (cytokines, chemokines, soluble receptors), secreted by Lymphocytes in the culture medium will be studied.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 VIH positive patients without lymphome + 20 VIH positive patients with lymphome + 20 healthy volunteers (VIH negative).
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062825


Contacts
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Contact: Claude Capron, MD +33(0)149095847 claude.capron@aphp.fr
Contact: MORGANE BOMSEL, MD +33(0)140516497 morgane.bomsel@inserm.fr

Locations
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France
Service Hématologie Immunologie, Hôpital Ambroise Paré
Boulogne Billancourt, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Claude Capron, MD Service Hématologie Immunologie, Hôpital Ambroise Paré
Study Director: 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
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04062825    
Other Study ID Numbers: 19CCN-VIH-Plaquettes
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
HIV
platelets
lymphocytes
cART
InRs
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases