Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04208711
Status:
UNKNOWN
Last Update Posted:
2021-02-08
First Post:
2019-12-02
Brief Title:
Role of PLA2G1B During HIV Infection
Sponsor:
Diaccurate SAS
Organization:
Diaccurate SAS
Study Overview
Official Title:
Study of the Role of PLA2G1B in the Immunopathogenicity by Action on CD4 T Cells During HIV Infection
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
PREDIACC
Brief Summary:
The main objective of this study is to qualify and quantify by microscopy techniques CD4 lymphocyte abnormalities during HIV infection in 7 patients who are naive to any ARV antiretroviral treatment and secondarily to follow the kinetics of reversion of the observed abnormalities as well as the evolution of the levels of PLA2G1B and its cofactor gp41 in 8 patients under ARV treatment
Detailed Description:
Antiretroviral therapy in HIV-infected patients has progressed significantly over the past two decades
Viral replication in patients who are complicit in their treatment regimen is greatly reduced below detection limits quantification by current and approved laboratory tests However the persistence of residual plasma replication of the virus creates an inflammatory state associated with certain pathologies accelerated aging and premature mortality If treatment is discontinued for any reason viral replication resumes within a few weeks in almost all patients
Alternative infections of inflammatory pathways in HIV can also play a critical role in the inflammatory process suppressed by treatment Members of the phospholipase A2 family can hydrolyze phospholipid molecules at the sn-2 position making it a question about lipid moieties One of the members the phospholipase A2 group1B PLA2G1B is found in the plasma of HIV-infected patients who are not receiving antiretroviral therapy Ex vivo this enzyme is able to induce a purified CD4 lymphocyte energy from donors as well as by inducing the lack of response to IL-7 interleukin-7 In the long term loss of response to IL-7 induces CD4 lymphopenia Therefore PLA2G1B must play an important role in the mechanism leading to HIV-infected patients becoming immunodeficient
At the clinical level we found that PLA2G1B activity increases in all HIV-infected patients and decreases after ARV treatment On the other hand for patients who are able to eliminate the HIV virus on therapy but whose immunological response remains low PLA2G1B activity remains high More interestingly in HIV Elite Controller patients PLA2G1B activity is not found in their plasma Overall there is a correlation between the different clinical groups viremic not on therapy ARV and virus removal with robust CD4 T-cell response virus removal with suboptimal CD4 T-cell response and HIV Elite Controller and the activity level of PLA2G1B in their plasma
The purpose of this study more generally is to study the role of PLA2G1B in CD4 lymphocytes and to analyze the reversion of its effects in the immunopathogenicity of HIV infection
In the main study 15 patients will be included The analysis of the first 7 patients will in addition meet the objectives of the study to determine the test that will allow the follow-up of the 8 other patients after ARV treatment The participation of the 7 patients in the study is limited to 1 one day
In the sub-study the last 8 patients following their inclusion in the main study will enter a follow-up phase of 12 months after they are put on ARV treatment The total duration of participation for the 8 patients will be 13 months
The main study is carried out by taking 50 mL of total blood and in the sub-study 30mL of blood sample will be taken during the follow-up visit at M1 M3 M6 M9 and 12 Months after ARV treatment
Viral replication in patients who are complicit in their treatment regimen is greatly reduced below detection limits quantification by current and approved laboratory tests However the persistence of residual plasma replication of the virus creates an inflammatory state associated with certain pathologies accelerated aging and premature mortality If treatment is discontinued for any reason viral replication resumes within a few weeks in almost all patients
Alternative infections of inflammatory pathways in HIV can also play a critical role in the inflammatory process suppressed by treatment Members of the phospholipase A2 family can hydrolyze phospholipid molecules at the sn-2 position making it a question about lipid moieties One of the members the phospholipase A2 group1B PLA2G1B is found in the plasma of HIV-infected patients who are not receiving antiretroviral therapy Ex vivo this enzyme is able to induce a purified CD4 lymphocyte energy from donors as well as by inducing the lack of response to IL-7 interleukin-7 In the long term loss of response to IL-7 induces CD4 lymphopenia Therefore PLA2G1B must play an important role in the mechanism leading to HIV-infected patients becoming immunodeficient
At the clinical level we found that PLA2G1B activity increases in all HIV-infected patients and decreases after ARV treatment On the other hand for patients who are able to eliminate the HIV virus on therapy but whose immunological response remains low PLA2G1B activity remains high More interestingly in HIV Elite Controller patients PLA2G1B activity is not found in their plasma Overall there is a correlation between the different clinical groups viremic not on therapy ARV and virus removal with robust CD4 T-cell response virus removal with suboptimal CD4 T-cell response and HIV Elite Controller and the activity level of PLA2G1B in their plasma
The purpose of this study more generally is to study the role of PLA2G1B in CD4 lymphocytes and to analyze the reversion of its effects in the immunopathogenicity of HIV infection
In the main study 15 patients will be included The analysis of the first 7 patients will in addition meet the objectives of the study to determine the test that will allow the follow-up of the 8 other patients after ARV treatment The participation of the 7 patients in the study is limited to 1 one day
In the sub-study the last 8 patients following their inclusion in the main study will enter a follow-up phase of 12 months after they are put on ARV treatment The total duration of participation for the 8 patients will be 13 months
The main study is carried out by taking 50 mL of total blood and in the sub-study 30mL of blood sample will be taken during the follow-up visit at M1 M3 M6 M9 and 12 Months after ARV treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A02025-50 | REGISTRY | ID-RCB | None |