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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: HIV-1 Infection

Treatments: Other: Blood tube bottom analyses

Study type: Observational

Funder types: Other

Identifiers

NCT02557997

6074

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

202 participants in 4 patient groups

ART-naive (primary infection)

Description:

ART-naive (primary infection) HIV infected adults

Treatment:

Other: Blood tube bottom analyses

ART-naïve (chronic infection)

Description:

ART-naïve (chronic infection) HIV infected adults

Treatment:

Other: Blood tube bottom analyses

ART-controlled

Description:

ART-controlled HIV infected adults

Treatment:

Other: Blood tube bottom analyses

ART-failing

Description:

ART-failing HIV infected adults

Treatment:

Other: Blood tube bottom analyses