Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    480
  • sponsor
    Erasmus Medical Center
Updated on 2 February 2021

Summary

This study aims to determine real-life clinical efficacy of virally suppressed patienst switching to DTG/3TC compared to DTG triple drug cART controls

Description

Dolutegravir (DTG) based dual antiretroviral therapy constitutes a paradigm shift from triple drug based therapy. Data outside clinical trials are scarce. This study evaluates the value of DTG/3TC in real life.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment Dolutegravir / Lamivudine Pill
Clinical Study IdentifierNCT04707326
SponsorErasmus Medical Center
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Plasma HIVRNA <50c/mL on triple drug cART regimen including 2NRTI In care in a
HIV treatment center in the Netherlands Consented to ATHENA participation

Exclusion Criteria

Documented mutations associated with 3TC or DTG resistance of at least low
level Documented inadherence by the treating physician or HepB coinfection
(cases only)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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