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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02370979
First received: January 26, 2015
Last updated: August 6, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
HIV-1 Infection
Biological: Blood samples
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Change from baseline in Proviral HIV-1 DNA at Week 48 [ Time Frame: baseline (Day 0) and Week 48 ]

Secondary Outcome Measures:
  • Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels) [ Time Frame: Week 4, Week 24 and Week 48 ]
  • Quantification of biomarkers of immune activation [ Time Frame: baseline (Day 0), Week 24 and Week 48 ]
    CRPus, IL-6, neopterin, D-dimer, CD14s


Estimated Enrollment: 202
Study Start Date: February 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dolutegravir Biological: Blood samples

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02370979

Contacts
Contact: Samira FAFI-KREMER, PhD +33369551438 samira.fafi-kremer@unistra.fr

Locations
France
Centre hospitalier de Belfort-Montbéliard Active, not recruiting
Belfort, France, 90000
Centre hospitalier de Colmar Recruiting
Colmar, France, 68024
Contact: Martin MARTINOT, MD       martin.martinot@ch-colmar.fr   
Centre hospitalier de Mulhouse Recruiting
Mulhouse Cedex, France, 68070
Contact: Geneviève BECK WIRTH, MD       beck-wirthg@ch-mulhouse.fr   
Hôpitaux Universitaire de Strasbourg Recruiting
Strasbourg Cedex, France, 67091
Contact: David REY, PhD       david.rey@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: David REY, PhD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02370979     History of Changes
Other Study ID Numbers: 5973
Study First Received: January 26, 2015
Last Updated: August 6, 2015

Keywords provided by University Hospital, Strasbourg, France:
Dolutegravir
Proviral HIV-1 DNA
Reservoir

Additional relevant MeSH terms:
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 25, 2017