Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
Phase 4
- Conditions
- HIV-1 Infection
- Interventions
- Biological: Blood samples
- Registration Number
- NCT02370979
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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.
- Detailed Description
Not available
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dolutegravir Blood samples -
- Primary Outcome Measures
Name Time Method Change from baseline in Proviral HIV-1 DNA at Week 48 baseline (Day 0) and Week 48
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Centre hospitalier de Belfort-Montbéliard
🇫🇷Belfort, France
Centre hospitalier de Colmar
🇫🇷Colmar, France
Centre hospitalier de Mulhouse
🇫🇷Mulhouse Cedex, France
Hôpitaux Universitaire de Strasbourg
🇫🇷Strasbourg Cedex, France