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

• Conditions: HIV-1 Infection

• Registration Number: NCT02557997
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2015-09
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Study First Posted: 2015-09-23
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Proviral HIV-1 DNA at Week 48	Baseline and 48 weeks post DTG-based regimen initiation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg - Trait d'Union; 🇫🇷 STRASBOURG Cedex, France