Active, not recruiting

Study Description:

DTG is a second-generation integrase strand transfer inhibitor (INSTI) with a high antiviral potency and a good safety profile, when used with nucleoside backbone in treatment-naive subjects. The data from CoRIS have shown that DTG discontinuations due to adverse events (AEs) were lower than those observed for elvitegravir and raltegravir containing regimens. As DTG is one of the preferred antiretroviral agents for initial antiretroviral treatment, larger cohort studies with long-term follow-up are needed to precisely define its overall performance with regard to AEs and tolerability. Thus, this study is designed to assess the use and effectiveness of DTG-based regimens in naive and virologically suppressed antiretroviral therapy (ART)-experienced subjects from CoRIS. CoRIS is an open, multicenter and prospective cohort of human immunodeficiency virus (HIV)-positive adults, naive to antiretroviral treatment. CoRIS collects a minimum dataset which includes Baseline and follow-up socio-demographic, immunological and clinical data including ART medication, with start and stop dates, as well as reasons for drug discontinuation. The persistence, immunological and virological responses of DTG-based regimens in naive and virologically suppressed ART-experienced subjects who initiated first-line antiretroviral regimens from 1st September 2014 to 30th November 2017 from the CoRIS will be evaluated in this study.

Viiv Study ID:

208569


Clinicaltrials.gov Identifier:

Not Available


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

GSK2326285;GSK3736631;GSK3858441;abacavir;abacavir/lamivudine;atazanavir;cobicistat;darunavir;dolutegravir;dolutegravir/abacavir/lamivudine;efavirenz;elvitegravir;emtricitabine;lamivudine;raltegravir;rilpivirine;ritonavir;tenofovir disoproxil fumarate

Collaborators

Institute Carlos III


Date

January 2018 to December 2019

Type

Observational

Phase

4


Gender

Both

Age

18 Years+

Accepts Healthy Volunteers


Study Documents

No documents available

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]


Study Design

  • Primary Purpose: Not Available
  • Allocation: Not Available
  • Study Design: Not Available
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Number of subjects initiating ART regimen
    Timeframe: Up to 169 weeks

  • Time to treatment modifications after initiation of ART
    Timeframe: Up to 144 weeks

  • Number of reasons for treatment modifications after initiation of ART
    Timeframe: Up to 144 weeks

  • Number of subjects with virological responses after initiation of ART
    Timeframe: Up to 144 weeks

  • Number of subjects with immunological responses after initiation of ART
    Timeframe: Up to 144 weeks

  • Number of reasons for switching to DTG-based dual regimen
    Timeframe: Up to 169 weeks

  • Time to virological failure before switching to DTG-based dual regimen
    Timeframe: Up to 169 weeks

  • Time to treatment modifications after switching to DTG-based dual regimen
    Timeframe: Up to 48 weeks

  • Number of reasons for treatment modifications after switching to DTG-based dual regimen
    Timeframe: Up to 48 weeks

  • Number of subjects with virological responses after switching to DTG-based dual regimen
    Timeframe: Up to 48 weeks

  • Number of subjects with immunological responses after switching to DTG-based dual regimen
    Timeframe: Up to 48 weeks

  • Time to confirmed virological failure
    Timeframe: Up to 48 weeks

  • Time to virological failure
    Timeframe: Up to 48 weeks

Arms:
  • N/A

Keyword:

  • Human immunodeficiency virus, CoRIS, Dolutegravir, Antiretroviral therapy
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 1000

Clinical Publications:

  • Alejos B, Suárez-García I, Bisbal O, et al.Choice of the initial antiretroviral treatment for HIV-positive individuals in the era of integrase inhibitors.PLoS ONE.2019;14(8)