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NCT Number: NCT04707326

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital, Arnhem, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dolutegravir / Lamivudine Pill

Drug

HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B

Primary outcomes

  1. Efficacy On Treatment (OT)

    Time frame: 1 year

    Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the on treatment population

  2. Efficacy Intention to Treat (ITT)

    Time frame: 1 year

    Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group up to 1 year of follow up in the intention to treat population.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Admiraal de Ruyter Hospital
  • Catharina Ziekenhuis Eindhoven
  • Elisabeth-TweeSteden Ziekenhuis
  • Haaglanden Medical Centre
  • Maasstad Hospital
  • Medisch Spectrum Twente
  • Rijnstate Hospital
  • Spaarne Gasthuis

Registry information

Official study title

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

Acronym: DUALING

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Jan 13, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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