drugset / Trial / NCT01910402

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

NCT01910402 ↗

Phase 3 Completed 499 enrolled ViiV Healthcare GlaxoSmithKline · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)

Timeline

Start: 2013-08-22
Primary completion: 2015-09-22
Completion: 2022-08-18

Outcome

Met primary endpoint

registry p = 0.005; Adjusted difference in proportion 10.5 (95% CI 3.1 to 17.8) NCT01910402 ↗

release “ARIA study which showed superior efficacy for Triumeq®” gsk.com ↗

release “Both non-inferiority and superiority endpoints were met” gsk.com ↗

release “ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both non-inferiority and superiority endpoints were met” gsk.com ↗

release “ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both non-inferiority and superiority endpoints were met.” gsk.com ↗

Publications

Orrell C, Hagins DP, Belonosova E, Porteiro N, Walmsley S, Falco V, Man CY, Aylott A, Buchanan AM, Wynne B, Vavro C, Aboud M, Smith KY; ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017 Dec;4(12):e536-e546. doi: 10.1016/S2352-3018(17)30095-4. Epub 2017 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	600 mg	Oral
Comparator	Atazanavir	Other / unclassified	300 mg	Oral
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Subject	Lamivudine	Other / unclassified	300 mg	Oral
Comparator	Ritonavir	Other / unclassified	100 mg	Oral
Comparator	Tenofovir	Small molecule	300 mg	Oral
Comparator	emtricitabine	Other / unclassified	200 mg	Oral