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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections

Interventions

Type	Name	Description
DRUG	Dolutegravir/abacavir/lamivudine FDC	Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
DRUG	Atazanavir	Atazanavir capsule 300 mg
DRUG	Ritonavir	Ritonavir tablet 100 mg
DRUG	Tenofovir/emtricitabine FDC	Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC

Timeline

• Start date: 2013-08-22
• Primary completion: 2015-09-22
• Completion: 2022-08-18
• First posted: 2013-07-29
• Last updated: 2024-02-20
• Results posted: 2016-10-31

Locations

90 sites across 13 countries: United States, Argentina, Canada, France, Italy, Mexico, Portugal, Puerto Rico, Russia, South Africa, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study