HivDUALINGNCT04707326

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

An observational study of Hiv, run by Erasmus Medical Center at 9 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hiv
What is being tested?: Dolutegravir / Lamivudine Pill
Type of treatment: Pill or oral medicine
How many people: 2,040 participants
Where: 9 sitesNetherlands
Study dates: 1 Nov 2019to 1 Nov 2026
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Netherlands9 sites

Rijnstate Hospital
Arnhem
Catharina Ziekenhuis
Eindhoven
Medisch Spectrum Twente
Enschede
Admiraal de Ruyter Ziekenhuis
Goes
Spaarne Gasthuis
Haarlem
Erasmus MC
Rotterdam, 3015 CN
MC Haaglanden
Rotterdam, 3015 CN
Maasstad Hospital
Rotterdam
Elisabeth Tweesteden Hospital
Tilburg

Other trials in Netherlands

About this study

Official title: 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

Read the 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.

Conditions: Hiv
Being tested: Dolutegravir / Lamivudine Pill
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dolutegravir / Lamivudine PillDrug
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

Study groups in NCT04707326
Study group	Role	What they receive
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		Not described Receives: Drug: Dolutegravir / Lamivudine Pill
non-DTG based triple drug cART		Matched HIVRNA suppressed patients who remained on triple drug non-DTG based cART

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20191 Nov 2026

First posted13 Jan 2021
Study start1 Nov 2019
Primary completion1 Nov 2023
Study completion1 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,040 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT04707326
Sponsor's protocol ID: DUALING
Acronym: DUALING
Status last verified: Dec 2024
First submitted: 12 Jan 2021
Last updated: 20 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Other research groups can contact the PI with a research question to obtain IPD.

Publications

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.
PubMed 38567196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study.
ClinicalTrials.gov ID: NCT04707326
Acronym / sponsor ID: DUALING / DUALING
Conditions: Hiv
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 2,040 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Collaborators: Maasstad Hospital, Haaglanden Medical Centre, Catharina Ziekenhuis Eindhoven, Elisabeth-TweeSteden Ziekenhuis, Rijnstate Hospital, Admiraal de Ruyter Hospital, Spaarne Gasthuis, Medisch Spectrum Twente
Study start: 1 Nov 2019 (actual)
Primary completion: 1 Nov 2023 (actual)
Study completion: 1 Nov 2026 (estimated)
First posted: 13 Jan 2021 (actual)
Results: Posted 20 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dolutegravir / Lamivudine PillHIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B	Drug	non-DTG based switchers to DTG/3TC

Primary outcome

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
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.

Results and safety

Results posted to the registry on 20 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DTG Based Switchers to DTG/3TC	390	390
DTG Based Triple Drug cART	780	780
Non-DTG Based Switchers to DTG/3TC	290	290
Non-DTG Based Triple Drug cART	580	580

Primary outcome: Efficacy On Treatment (OT)

Time frame: 1 year. Count of participants. Unit: Participants

Measure	DTG Based Switchers to DTG/3TC n = 361	DTG Based Triple Drug cART n = 628	Non-DTG Based Switchers to DTG/3TC n = 260	Non-DTG Based Triple Drug cART n = 506
Value	5	5	2	4

Primary outcome: Efficacy Intention to Treat (ITT)

Time frame: 1 year. Count of participants. Unit: Participants

Measure	DTG Based Switchers to DTG/3TC n = 390	DTG Based Triple Drug cART n = 780	Non-DTG Based Switchers to DTG/3TC n = 290	Non-DTG Based Triple Drug cART n = 580
Value	34	89	32	73

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTG Based Switchers to DTG/3TC	0 of 390 (0%)	0 of 390 (0%)	0 of 390
DTG Based Triple Drug cART	0 of 780 (0%)	0 of 780 (0%)	0 of 780
Non-DTG Based Switchers to DTG/3TC	0 of 290 (0%)	0 of 290 (0%)	0 of 290
Non-DTG Based Triple Drug cART	0 of 580 (0%)	0 of 580 (0%)	0 of 580

Limitations and caveats (from the sponsor): All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were collected during this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38567196Vasylyev 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.
Individual participant dataSharing planned: Yes. Other research groups can contact the PI with a research question to obtain IPD.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hiv, run by Erasmus Medical Center at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy On Treatment (OT) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.