Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441123
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Development of a New Family of HIV Latency Regulators LRAs Targeting the Tat Viral Protein
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Development of a New Family of HIV Latency Regulators LRAs Targeting the Tat Viral Protein
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
TatLat
Brief Summary:
Antiretroviral therapy ART prevents HIV from multiplying However if people living with HIV stop taking ART the virus quickly reappears in their blood due to the random activation of hidden infected cells These hidden cells contain HIV that is not active and do not produce the virus These cells are a major challenge in finding a cure for HIV
One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents LRAs This process known as the shock-and-kill strategy involves waking up the hidden virus shock phase so that it can be destroyed by the bodys immune system or by the virus itself kill phase
Investigators are developing new LRAs that target and activate a viral protein called Tat which is necessary for the virus to start producing again and for reversing its dormant stateThe lead compound named D10 is the first of its kind to target the Tat protein This compound has been patented and has shown activity in activating the virus in lab-grown cells Now investigators need to test its effectiveness on real target cells from people living with HIV
One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents LRAs This process known as the shock-and-kill strategy involves waking up the hidden virus shock phase so that it can be destroyed by the bodys immune system or by the virus itself kill phase
Investigators are developing new LRAs that target and activate a viral protein called Tat which is necessary for the virus to start producing again and for reversing its dormant stateThe lead compound named D10 is the first of its kind to target the Tat protein This compound has been patented and has shown activity in activating the virus in lab-grown cells Now investigators need to test its effectiveness on real target cells from people living with HIV
Detailed Description:
20 ml of blood 5 tubes of 4 ml each will be collected from 24 people living with HIV who are on ART The inclusion criteria for this study are being HIV-positive having an undetectable viral load for more than 12 months and having a history of very low T-CD4 counts nadir 200 cellsmm³
In the lab investigators will isolate immune cells PBMCs from the blood using a special technique These cells will then be placed in small wells and treated with LRAs for 18-20 hours Investigators will measure the virus produced in the cell supernatant using two methods q-RT-PCR for viral RNA and p24 ELISA for viral protein The results will be analyzed using conventional statistical methods
In the lab investigators will isolate immune cells PBMCs from the blood using a special technique These cells will then be placed in small wells and treated with LRAs for 18-20 hours Investigators will measure the virus produced in the cell supernatant using two methods q-RT-PCR for viral RNA and p24 ELISA for viral protein The results will be analyzed using conventional statistical methods
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