Impact of Starting a Dolutegravir-based Regimen on HIV-1... | NCT02370979

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

NCT02370979

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Aug 7, 2015Estimated

Enrollment

202Estimated

Phase

Phase 4

Conditions

HIV-1 Infection

Interventions

Blood samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Feb 18, 2015

First Posted Date

Feb 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2015

Last Update Posted Date

Aug 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Estimated

Label	Type	Description	Intervention Names
Dolutegravir	Experimental		Biological: Blood samples

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Biological		Dolutegravir

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)		Week 4, Week 24 and Week 48
Quantification of biomarkers of immune activation	CRPus, IL-6, neopterin, D-dimer, CD14s

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samira FAFI-KREMER, PhD	Contact	+33369551438		samira.fafi-kremer@unistra.fr

Overall Officials

Name	Affiliation	Role
David REY, PhD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier de Belfort-Montbéliard	Active, not recruiting	Belfort		90000	France

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided