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

August 6, 2015 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Belfort, France, 90000
        • Active, not recruiting
        • Centre Hospitalier de Belfort-Montbeliard
      • Colmar, France, 68024
      • Mulhouse Cedex, France, 68070
      • Strasbourg Cedex, France, 67091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dolutegravir
Biological: Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Proviral HIV-1 DNA at Week 48
Time Frame: baseline (Day 0) and Week 48
baseline (Day 0) and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)
Time Frame: Week 4, Week 24 and Week 48
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
baseline (Day 0), Week 24 and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: David REY, PhD, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5973

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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