HIV-1 Infection
Conditions
Keywords
Dolutegravir, Proviral HIV-1 DNA, Reservoir
Brief summary
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.
Interventions
BIOLOGICALBlood samples
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Proviral HIV-1 DNA at Week 48 | baseline (Day 0) and Week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels) | Week 4, Week 24 and Week 48 | — |
| Quantification of biomarkers of immune activation | baseline (Day 0), Week 24 and Week 48 | CRPus, IL-6, neopterin, D-dimer, CD14s |
Countries
France
Contacts
Primary ContactSamira FAFI-KREMER, PhD
Outcome results
None listed