Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

Study Overview
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Brief Summary
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We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.

Official Title
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Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Other: Blood tube bottom analyses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged from de 18 to 80 years Patient starting a DTG-regimen Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening Exclusion Criteria: Women who are pregnant or breastfeeding HBV or HCV coinfection Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted Documented resistance to DTG Allergy or intolerance to the study drugs or their components or drugs of their class Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening. Coadministration with Dofelitide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ART-naive (primary infection)<br>ART-naive (primary infection) HIV infected adults | Other: Blood tube bottom analyses<br> <br> |
| ART-naïve (chronic infection)<br>ART-naïve (chronic infection) HIV infected adults | Other: Blood tube bottom analyses<br> <br> |
| ART-controlled<br>ART-controlled HIV infected adults | Other: Blood tube bottom analyses<br> <br> |
| ART-failing<br>ART-failing HIV infected adults | Other: Blood tube bottom analyses<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Proviral HIV-1 DNA at Week 48 |  | Baseline and 48 weeks post DTG-based regimen initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of biomarkers of immune activation | Soluble CD14 (sCD14), soluble CD163 (sCD163), neopterine, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) | Baseline, 24 and 48 weeks post DTG-based regimen initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV reservoir, HIV-1 DNA, Immune activation, Monocyte function, Activation biomarkers