Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02691065
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2016-02-17
Brief Title:
Protease Inhibitor vs Raltegravir-based ART and Inflammation in HIV Infection
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Effect of a Treatment Switch From Protease Inhibitor to Raltegravir-based ART on Myeloid Cell Inflammation in HIV-infected Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
Human immunodeficiency virus HIV infection damages body defence mainly by affecting two important white blood cells called cluster of differentiation CD4 T cells and monocytes This immune dysfunction leads to persistent inflammation which is partially resolved with long-term anti-HIV therapy Importantly such inflammation increases risk for cardiovascular diabetes and kidney diseases The causes of this inflammation are largely unknown and include HIV itself presence of other infections lifestyle characteristics like increased cholesterol levels obesity smoking and alcohol abuse In addition inflammation can be driven by certain type of anti-HIV therapy called protease inhibitor PI PI has been associated with an increase of cholesterol and may contribute to inflammation A new class of medication that is now available in Canada called integrase inhibitor II may have a lesser or no effect on cholesterol levels Therefore it is important to study the effect of II on cholesterol levels and inflammation
The purpose of this study is to assess the inflammatory changes in the blood of persons treated with PI that will switch to the II or may remain on their PI-containing regimen By comparing persons continuing their current PI-based regimen with those who switch to II-based regimen we will know if the change from PI to raltegravir Isentress a type of II decreases lipids and inflammatory markers
The adult persons living with HIV who are on PI-based therapy for more than a year with any CD4 T cell count and plasma viral load below level of detection will be invited to participate in the study 40 study participants will be selected by randomization like a toss of a coin to either continue PI-based regimen 20 participants or switch to raltegravir-based regimen 20 participants for a period of 12 months Blood samples of the study participants will be drawn before during and at the end of study to evaluate changes in markers of inflammation cholesterol level and CD4 T cell and monocyte function No experimental anti-HIV medication will be used change of therapy will include raltegravir which is one of currently recommended medications to treat HIV in Canada
This study will be able to answer this important question whether inflammation can be decreased by switching therapy from PI-based therapy to raltegravir-based therapy Ultimately information provided by this study will contribute to the health of persons living with HIV
The purpose of this study is to assess the inflammatory changes in the blood of persons treated with PI that will switch to the II or may remain on their PI-containing regimen By comparing persons continuing their current PI-based regimen with those who switch to II-based regimen we will know if the change from PI to raltegravir Isentress a type of II decreases lipids and inflammatory markers
The adult persons living with HIV who are on PI-based therapy for more than a year with any CD4 T cell count and plasma viral load below level of detection will be invited to participate in the study 40 study participants will be selected by randomization like a toss of a coin to either continue PI-based regimen 20 participants or switch to raltegravir-based regimen 20 participants for a period of 12 months Blood samples of the study participants will be drawn before during and at the end of study to evaluate changes in markers of inflammation cholesterol level and CD4 T cell and monocyte function No experimental anti-HIV medication will be used change of therapy will include raltegravir which is one of currently recommended medications to treat HIV in Canada
This study will be able to answer this important question whether inflammation can be decreased by switching therapy from PI-based therapy to raltegravir-based therapy Ultimately information provided by this study will contribute to the health of persons living with HIV
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?:
False
Is an FDA AA801 Violation?:
None