Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test

Phase 4 Completed 244 enrolled Fundacion IDEAA ViiV Healthcare · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.

Timeline

Start: 2020-11-17
Primary completion: 2023-09-30
Completion: 2023-09-30

Outcome

Met primary endpoint

paper showing non-inferiority of dolutegravir plus lamivudine to the three-drug regimen. PMID 39826566 ↗

Publications

Cordova E, Hernandez Rendon J, Mingrone V, Martin P, Arevalo Calderon G, Seleme S, Ballivian J, Porteiro N. Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial. Lancet HIV. 2025 Feb;12(2):e95-e104. doi: 10.1016/S2352-3018(24)00294-7. Epub 2025 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lamivudine	Other / unclassified	300 mg	—
Comparator	Tenofovir disoproxil fumarate	Small molecule	300 mg	—
Comparator	emtricitabine	Other / unclassified	200 mg	—
Background	Dolutegravir	Other / unclassified	50 mg	—