HIV-1 Infection
Conditions
Keywords
HIV reservoir, HIV-1 DNA, Immune activation, Monocyte function, Activation biomarkers
Brief summary
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.
Interventions
OTHERBlood tube bottom analyses
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Proviral HIV-1 DNA at Week 48 | Baseline and 48 weeks post DTG-based regimen initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of biomarkers of immune activation | Baseline, 24 and 48 weeks post DTG-based regimen initiation | Soluble CD14 (sCD14), soluble CD163 (sCD163), neopterine, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) |
Countries
France
Contacts
Primary ContactSamira FAFI-KREMER, PhD
Backup ContactPierre GANTNER, PhD
Outcome results
None listed