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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2024-02-20

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-22
Primary Completion
2015-09-22
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Italy
  • Mexico
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910402 on ClinicalTrials.gov