Clinical trial NCT02557997: Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
Official title: Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1 Infection
Keywords: HIV reservoir
HIV-1 DNA
Immune activation
Monocyte function
Activation biomarkers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting an HIV Infection care center at a university hospital will be selected

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Proviral HIV-1 DNA at Week 48
timeFrame: Baseline and 48 weeks post DTG-based regimen initiation
Secondary outcomes:
measure: Quantification of biomarkers of immune activation
timeFrame: Baseline, 24 and 48 weeks post DTG-based regimen initiation
Other outcomes:
Locations:
city: STRASBOURG Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg - Trait d'Union
Study officials:
References:
citation: Gantner P, Barnig C, Partisani M, Lee GQ, Beck-Wirth G, Faller JP, Martinot M, Mosheni-Zadeh M, Cheneau C, Batard ML, Fischer P, Fuchs A, Uring-Lambert B, Bahram S, Rey D, Fafi-Kremer S. Distribution and reduction magnitude of HIV-DNA burden in CD4+ T cell subsets depend on art initiation timing. AIDS. 2018 Apr 24;32(7):921-926. doi: 10.1097/QAD.0000000000001770.
citation: Gantner P, Lee GQ, Rey D, Mesplede T, Partisani M, Cheneau C, Beck-Wirth G, Faller JP, Mohseni-Zadeh M, Martinot M, Wainberg MA, Fafi-Kremer S. Dolutegravir reshapes the genetic diversity of HIV-1 reservoirs. J Antimicrob Chemother. 2018 Apr 1;73(4):1045-1053. doi: 10.1093/jac/dkx475.