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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02370979
Recruitment Status : Unknown
Verified August 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : February 25, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Biological: Blood samples Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dolutegravir Biological: Blood samples


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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370979


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

Locations
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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
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Principal Investigator: David REY, PhD Hôpitaux Universitaires de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02370979    
Other Study ID Numbers: 5973
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by University Hospital, Strasbourg, France:
Dolutegravir
Proviral HIV-1 DNA
Reservoir