Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03618862
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2018-08-01
Brief Title:
Study of the Effects of Farnesoid X Receptor FXR Ligands on the Reactivation of Latent Provirus
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Study of the Effects of Farnesoid X Receptor FXR Ligands on the Reactivation of Latent Provirus in Circulating CD4 T Cells Isolated From Patients With Undetectable HIV Viremia Under cART
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FXReservoir
Brief Summary:
The Farnesoid X receptor FXR is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism A recent study opens the hypothesis that Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes This hypothesis implied that modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus replication The results of in vitro studies with Human Immunodeficiency Virus-infected cell lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death the overall effect is therefore antiviral Farnesoid X receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies This last data raises the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus
It is therefore crucial to confirm on quiescent CD4 T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models
Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART Human Immunodeficiency Virus-positive patients will be any patients irrespective of the viral genotype who initiated antiretroviral therapy regardless of the combination of antiretrovirals away from primary infection when they already had a complete western blot indicating an evolution of the infection without treatment and constitution of an already evolved reservoir Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 T lymphocytes mm3
It is therefore crucial to confirm on quiescent CD4 T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models
Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART Human Immunodeficiency Virus-positive patients will be any patients irrespective of the viral genotype who initiated antiretroviral therapy regardless of the combination of antiretrovirals away from primary infection when they already had a complete western blot indicating an evolution of the infection without treatment and constitution of an already evolved reservoir Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 T lymphocytes mm3
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None