Protease Inhibitor vs. Raltegravir-based ART and Inflammation in HIV Infection
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|ClinicalTrials.gov Identifier: NCT02691065|
Recruitment Status : Unknown
Verified September 2016 by Jean-Pierre Routy, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was: Not yet recruiting
First Posted : February 25, 2016
Last Update Posted : September 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Integrase Inhibitor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Treatment Switch From Protease Inhibitor to Raltegravir-based ART on Myeloid Cell Inflammation in HIV-infected Patients.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Integrase Inhibitor
Switch from protease inhibitor-based regimen to raltegravir-based regimen
Drug: Integrase Inhibitor
No Intervention: Protease inhibitor
Continuation of protease-inhibitor based regimen
- Reduction in the frequency of inflammatory monocytes [ Time Frame: 12 months ]Phenotypic assessment of peripheral blood monocytes by flow cytometry to determine the percentage of CD14+ CD16+ monocytes. This will be compared between two arms to determine the effect of Raltegravir-based therapy vs protease inhibitor-based therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691065
|Contact: Natacha Cotta-Grand, PhD||(514) 934 -1934 ext email@example.com|
|Chronic Viral Illness Service, McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|
|Principal Investigator:||Jean-Pierre Routy, MD; FRCPC||McGill University Health Centre/Research Institute of the McGill University Health Centre|