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

NCT04707326 | Active Not Recruiting Results FDA Drug

• 1 other identifier: DUALING
• Study Type: observational
• Target: 2,040
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Hiv

Outcome Measures

Primary Outcomes (2)

• Efficacy On Treatment (OT)

  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

  1 year

• Efficacy Intention to Treat (ITT)

  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.

  1 year

Study Arms (4)

DTG based switchers to DTG/3TC

HIVRNA suppressed HIV patients who switched to DTG/3TC

DTG based triple drug cART

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

non-DTG based switchers to DTG/3TC

Drug: Dolutegravir / Lamivudine Pill

non-DTG based triple drug cART

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

Interventions

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

non-DTG based switchers to DTG/3TC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To be eligible as case in the study, plasma HIVRNA must be \<50c/mL on triple drug cART containing 2NRTI at switch to DTG/3TC and no key mutations associated with major 3TC (i.e. M184V/I only) or DTG resistance of at least low level according to the Stanford HIV drug resistance database should be present. Patients with no genotyping results available at baseline will be eligible for inclusion in this study. Cases should not have documented inadherence in the preceding 3 months or HepB coinfections. These data on adherence and HepB is routinely collected at switching to DTG/3TC. Controls are matched on predefined criteria.

You may qualify if:

• 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

You may not qualify if:

• Documented mutations associated with 3TC or DTG resistance of at least low level Documented inadherence by the treating physician or HepB coinfection (cases only)

Sponsors & Collaborators

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

Study Sites (9)

Rijnstate Hospital

Arnhem, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

MC Haaglanden

Rotterdam, 3015 CN, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Elisabeth Tweesteden Hospital

Tilburg, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38567196 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravir; Lamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Limitations and Caveats

All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were collected during this study.

Results Point of Contact

• Title: Dr. Casper Rokx
• Organization: ErasmusMC

c.rokx@erasmusmc.nl

+310107040704

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: November 1, 2019
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Up to 15 years

Locations

NL (9)