Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626555
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Clinical Trial to Evaluate the Effects of Letermovir Prophylaxis on T-cell Immune Activation in Participants With Treated HIV-1 Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Randomized Open-Label Non-Active Comparator Controlled Clinical Trial to Evaluate the Effects of Letermovir Prophylaxis on T-cell Immune Activation in Participants With Treated HIV-1 Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACTIV
Brief Summary:
People living with HIV PLWH even with an undetectable viral load VL on antiretroviral treatment ART develop health conditions such as heart disease diabetes various cancers and conditions that can affect the brain more commonly than the general population
These conditions occur earlier in PLWH compared to HIV negative individuals with similar lifestyles Ongoing inflammation in the body despite antiretroviral therapy is thought to be contributing to the development of these conditions that can affect healthy ageing in PLWH
Cytomegalovirus CMV is a very common infection in PLWH and is an important driver of inflammation in the body that can affect the function of the immune immune cells in the body defense system causing unwanted activation and damage of the gut making it more leaky A drug with potent activity against CMV called valganciclovir has previously shown to reduce this potentially damaging inflammation in the body
In this study the investigators want to investigate if a new drug called Letermovir in combination with HIV treatment will prevent CMV from replicating multiplying and thereby reduce inflammation in the body Letermovir has received approval to prevent CMV from multiplying in patients receiving bone marrow transplants It has been shown to have a more favourable side-effect profile compared to other available drugs and is predicted to interact little with anti-HIV drugs
The aim of this study is to find out if the letermovir is safe and effective in reducing CMV related immune activation and inflammation PLWH These findings will be used to help us design larger studies to identify individuals who would benefit most from this treatment to prevent the development of health conditions that can affect their quality of life
These conditions occur earlier in PLWH compared to HIV negative individuals with similar lifestyles Ongoing inflammation in the body despite antiretroviral therapy is thought to be contributing to the development of these conditions that can affect healthy ageing in PLWH
Cytomegalovirus CMV is a very common infection in PLWH and is an important driver of inflammation in the body that can affect the function of the immune immune cells in the body defense system causing unwanted activation and damage of the gut making it more leaky A drug with potent activity against CMV called valganciclovir has previously shown to reduce this potentially damaging inflammation in the body
In this study the investigators want to investigate if a new drug called Letermovir in combination with HIV treatment will prevent CMV from replicating multiplying and thereby reduce inflammation in the body Letermovir has received approval to prevent CMV from multiplying in patients receiving bone marrow transplants It has been shown to have a more favourable side-effect profile compared to other available drugs and is predicted to interact little with anti-HIV drugs
The aim of this study is to find out if the letermovir is safe and effective in reducing CMV related immune activation and inflammation PLWH These findings will be used to help us design larger studies to identify individuals who would benefit most from this treatment to prevent the development of health conditions that can affect their quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None