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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04707326
Acronym
DUALING
Enrollment
2040
Registered
2021-01-13
Start date
2019-11-01
Completion date
2026-11-01
Last updated
2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

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

Detailed 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.

Interventions

DRUGDolutegravir / 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

Sponsors

Maasstad Hospital
CollaboratorOTHER
Haaglanden Medical Centre
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
Elisabeth-TweeSteden Ziekenhuis
CollaboratorOTHER
Rijnstate Hospital
CollaboratorOTHER
Admiraal de Ruyter Hospital
CollaboratorOTHER
Spaarne Gasthuis
CollaboratorOTHER
Medisch Spectrum Twente
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Efficacy On Treatment (OT)1 yearProportion 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
Efficacy Intention to Treat (ITT)1 yearProportion 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.

Countries

Netherlands

Participant flow

Participants by arm

ArmCount
DTG Based Switchers to DTG/3TC
HIVRNA suppressed HIV patients who switched to DTG/3TC
390
DTG Based Triple Drug cART
Matched HIVRNA suppressed patients who remained on triple drug DTG based cART
780
Non-DTG Based Switchers to DTG/3TC
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
290
Non-DTG Based Triple Drug cART
Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART
580
Total2,040

Baseline characteristics

CharacteristicDTG Based Switchers to DTG/3TCDTG Based Triple Drug cARTNon-DTG Based Switchers to DTG/3TCNon-DTG Based Triple Drug cARTTotal
Age, Continuous48 years48 years50 years50 years49 years
CD4 count nadir330 cells/mcL310 cells/mcL290 cells/mcL270 cells/mcL300 cells/mcL
Ethnicity (NIH/OMB)
Hispanic or Latino
34 Participants100 Participants35 Participants79 Participants248 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
356 Participants680 Participants255 Participants501 Participants1792 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
46 Participants92 Participants61 Participants122 Participants321 Participants
Sex: Female, Male
Male
344 Participants688 Participants229 Participants458 Participants1719 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 3900 / 7800 / 2900 / 580
other
Total, other adverse events
0 / 3900 / 7800 / 2900 / 580
serious
Total, serious adverse events
0 / 3900 / 7800 / 2900 / 580

Outcome results

Primary

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.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DTG Based Switchers to DTG/3TCEfficacy Intention to Treat (ITT)34 Participants
DTG Based Triple Drug cARTEfficacy Intention to Treat (ITT)89 Participants
Non-DTG Based Switchers to DTG/3TCEfficacy Intention to Treat (ITT)32 Participants
Non-DTG Based Triple Drug cARTEfficacy Intention to Treat (ITT)73 Participants
Primary

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

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DTG Based Switchers to DTG/3TCEfficacy On Treatment (OT)5 Participants
DTG Based Triple Drug cARTEfficacy On Treatment (OT)5 Participants
Non-DTG Based Switchers to DTG/3TCEfficacy On Treatment (OT)2 Participants
Non-DTG Based Triple Drug cARTEfficacy On Treatment (OT)4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026