Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
DRONE
1 other identifier
interventional
202
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2015
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 7, 2015
August 1, 2015
2.4 years
January 26, 2015
August 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Proviral HIV-1 DNA at Week 48
baseline (Day 0) and Week 48
Secondary Outcomes (2)
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
Study Arms (1)
Dolutegravir
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre hospitalier de Belfort-Montbéliard
Belfort, 90000, France
Centre hospitalier de Colmar
Colmar, 68024, France
Centre hospitalier de Mulhouse
Mulhouse, 68070, France
Hôpitaux Universitaire de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David REY, PhD
Hôpitaux Universitaires de Strasbourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
February 25, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
August 7, 2015
Record last verified: 2015-08