Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

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
• An active AIDS-defining condition at Screening
• 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