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

University Hospital, Strasbourg, France202 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

202

Conditions

HIV-1 Infection

Interventions

Blood tube bottom analysesOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in Proviral HIV-1 DNA at Week 48

Time frame: Baseline and 48 weeks post DTG-based regimen initiation

Secondary Outcomes

Quantification of biomarkers of immune activation

Soluble CD14 (sCD14), soluble CD163 (sCD163), neopterine, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP)

Time frame: Baseline, 24 and 48 weeks post DTG-based regimen initiation