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

December 12, 2024 updated by: Casper Rokx, Erasmus Medical Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2040

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long term efficacy
Time Frame: 5 year
Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug DTG containing cART group after 2 and 5 year of follow up in the OT and ITT population.
5 year
Long term efficacy subgroups
Time Frame: 5 years
Proportion of subjects with treatment failure in the DTG/3TC versus 3-drug cART overall, and according to INSTI/PI/NNRTI (non-DTG) subgroups, after 1, 2 and 5 year of follow up in the OT and ITT population.
5 years
Time to event analysis
Time Frame: 5 years
Time to treatment failure in the DTG/3TC versus 3-drug DTG containing cART group and 3drug cART overall (including according to INSTI/PI/NNRTI (non-DTG) subgroups) according to the ITT and the OT population during 1, 2 and 5 years of follow up.
5 years
Plasma viral load
Time Frame: 5 years
Proportion of plasma viral load measurements above the limit of detection of the PCR but <50 (between 20 and 50 c/mL), proportion of viral blips of HIVRNA >50 once with plasma HIVRNA measured <=50 c/mL before and after, proportion of plasma HIVRNA >200 and >1000c/mL on DTG/3TC versus 3-drug DTG containing cART group and 3drug cART overall and according to INSTI/PI/NNRTI (non-DTG) subgroups.
5 years
Drug associated resistance
Time Frame: 5 years
Proportion of patients with emergent mutations associated with resistance to DTG, 3TC or the third antiviral agent in cases versus controls.
5 years
Treatment failure predictors
Time Frame: 5 years
Predictor variables for treatment failure in the DTG/3TC, 3-drug (non) DTG containing cART group and 3drug cART overall at the 1, 2, and 5 years of follow up in the OT and ITT population according to 1) sex, 2) ethnicity (Caucasian, African, other), 3) CD4+Tcell nadir, 4) HIVRNA zenith, duration of suppressive cART (</>1year and </>5 year), 5) presence of mutations, 6) CD4/CD8 ratio nadir 7) documented history in ATHENA database of virological failure (without selection of M184VI or major DTG related RAMs) or inadherence.
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interim analysis
Time Frame: 3 and 4 years
Analysis of endpoints at 3 and 4 years of follow up
3 and 4 years
Side effects
Time Frame: 5 years
Proportion of subjects with switches due to side effects in the DTG/3TC versus 3-drug (non) DTG containing cART group and 3drug cART overall after 1, 2, 3, 4 and 5 years of follow up
5 years
Cost-effectiveness
Time Frame: 5 years
Cost-effectiveness analysis of the switch from triple cART to DTG/3TC.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Rijnstate Hospital
Maasstad Hospital
Spaarne Gasthuis
Medisch Spectrum Twente
Admiraal de Ruyter Hospital
Haaglanden Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DUALING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Other research groups can contact the PI with a research question to obtain IPD.

IPD Sharing Time Frame

Up to 15 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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