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

University Hospital, Strasbourg, France

Status and phase

Unknown

Phase 4

Conditions

HIV-1 Infection

Treatments

Biological: Blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02370979

5973

Details and patient eligibility

About

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.

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
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