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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dolutegravir

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

Interventions

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Blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No