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

NCT ID: NCT04707326

Last Updated: 2024-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2040 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2026-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hiv

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DTG based switchers to DTG/3TC

HIVRNA suppressed HIV patients who switched to DTG/3TC

No interventions assigned to this group

DTG based triple drug cART

Matched HIVRNA suppressed patients who remained on triple drug DTG based cART

No interventions assigned to this group

non-DTG based switchers to DTG/3TC

Dolutegravir / Lamivudine Pill

Intervention Type 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

non-DTG based triple drug cART

Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART

No interventions assigned to this group

Interventions

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Dolutegravir / Lamivudine Pill

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maasstad Hospital

OTHER

Sponsor Role collaborator

Haaglanden Medical Centre

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Admiraal de Ruyter Hospital

OTHER

Sponsor Role collaborator

Spaarne Gasthuis

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Casper Rokx

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

Admiraal de Ruyter Ziekenhuis

Goes, , Netherlands

Site Status

Spaarne Gasthuis

Haarlem, , Netherlands

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

MC Haaglanden

Rotterdam, , Netherlands

Site Status

Maasstad Hospital

Rotterdam, , Netherlands

Site Status

Elisabeth Tweesteden Hospital

Tilburg, , Netherlands

Site Status

Countries

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Netherlands

References

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Vasylyev M, Wit FWNM, Jordans CCE, Soetekouw R, van Lelyveld SFL, Kootstra GJ, Delsing CE, Ammerlaan HSM, van Kasteren MEE, Brouwer AE, Leyten EMS, Claassen MAA, Hassing RJ, den Hollander JG, van den Berge M, Roukens AHE, Bierman WFW, Groeneveld PHP, Lowe SH, van Welzen BJ, Richel O, Nellen JF, van den Berk GEL, van der Valk M, Rijnders BJA, Rokx C. Dolutegravir/Lamivudine Is Noninferior to Continuing Dolutegravir- and Non-Dolutegravir-Based Triple-Drug Antiretroviral Therapy in Virologically Suppressed People With Human Immunodeficiency Virus: DUALING Prospective Nationwide Matched Cohort Study. Open Forum Infect Dis. 2024 Mar 18;11(4):ofae160. doi: 10.1093/ofid/ofae160. eCollection 2024 Apr.

Reference Type DERIVED
PMID: 38567196 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DUALING

Identifier Type: -

Identifier Source: org_study_id