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
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.
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|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|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|
VIH positive patients without lymphoma
200 VIH positive patients without lymphoma
VIH positive patients with lymphoma
20 VIH positive patients with lymphoma
20 healthy volunteers
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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.
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
|Contact: Claude Capron, MD||+33(0)firstname.lastname@example.org|
|Contact: MORGANE BOMSEL, MD||+33(0)email@example.com|
|Service Hématologie Immunologie, Hôpital Ambroise Paré|
|Boulogne Billancourt, France, 92100|
|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|