Completed PHASE3 INTERVENTIONAL 2-arm 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)

A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women

Sponsor: GlaxoSmithKline

Conditions HIV Infections Infection, Human Immunodeficiency Virus

Interventions Atazanavir Dolutegravir/abacavir/lamivudine FDC Ritonavir Tenofovir/emtricitabine FDC

Updated 20 times since 2017 Last updated: Feb 14, 2024 Started: Aug 22, 2013 Primary completion: Sep 22, 2015 Completion: Aug 18, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01910402, this PHASE3 trial focuses on HIV Infections and Infection, Human Immunodeficiency Virus and remains completed. Sponsored by GlaxoSmithKline, it has been updated 20 times since 2013, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

20 versions recorded

Oct 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Oct 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Mar 2024 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 15 earlier versions

Aug 2023 — Mar 2024 [monthly]

Completed PHASE3
Oct 2022 — Aug 2023 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Sep 2022 — Oct 2022 [monthly]

Active Not Recruiting PHASE3
Mar 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE3
Jan 2022 — Mar 2022 [monthly]

Active Not Recruiting PHASE3
Dec 2021 — Jan 2022 [monthly]

Active Not Recruiting PHASE3
Oct 2021 — Dec 2021 [monthly]

Active Not Recruiting PHASE3
May 2021 — Oct 2021 [monthly]

Active Not Recruiting PHASE3
Jan 2021 — May 2021 [monthly]

Active Not Recruiting PHASE3
Apr 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE3
Jun 2018 — Apr 2020 [monthly]

Active Not Recruiting PHASE3
Dec 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE3
Jul 2017 — Dec 2017 [monthly]

Active Not Recruiting PHASE3
Feb 2017 — Jul 2017 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Aug 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline
ViiV Healthcare

Data source: ViiV Healthcare

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

(Móstoles) Madrid, Spain , Alicante, Spain , Allentown, United States , Amadora, Portugal , Atlanta, United States , Augusta, United States , Badalona, Spain , Bakersfield, United States , Bangkok, Thailand , Barcelona, Spain and 70 more locations