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

Hiv Clinical Trial

— DUALING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707326
• Other study ID #: DUALING
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: November 1, 2025

Study information

• Verified date: January 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hiv

Intervention

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

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Admiraal de Ruyter Ziekenhuis	Goes
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Erasmus MC	Rotterdam
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	MC Haaglanden	Rotterdam
Netherlands	Elisabeth Tweesteden Hospital	Tilburg

Sponsors (9)

Lead Sponsor	Collaborator
Erasmus Medical Center	Admiraal de Ruyter Hospital, Goes, Catharina Ziekenhuis Eindhoven, Elisabeth Hospital, Tilburg, Maasstad Hospital, Rotterdam, MC Haaglanden, The Hague, MST, Enschede, Rijnstate Hospital Arnhem, Spaarne Gasthuis, Haarlem

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interim analysis	Analysis of endpoints at 3 and 4 years of follow up	3 and 4 years
Other	Side effects	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
Other	Cost-effectiveness	Cost-effectiveness analysis of the switch from triple cART to DTG/3TC.	5 years
Primary	Efficacy 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 OT population	1 year
Primary	Efficacy 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 ITT population.	1 year
Secondary	Long term efficacy	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
Secondary	Long term efficacy subgroups	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
Secondary	Time to event analysis	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
Secondary	Plasma viral load	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
Secondary	Drug associated resistance	Proportion of patients with emergent mutations associated with resistance to DTG, 3TC or the third antiviral agent in cases versus controls.	5 years
Secondary	Treatment failure predictors	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 (	5 years