CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 499 enrolled
Drug / intervention
Dolutegravir/abacavir/lamivudine FDC +3 moredrug
Likely dose
Dolutegravir/abacavir/lamivudine FDC 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01910402
NCT01910402Phase 3Completed
CompareCT.gov

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

ViiV Healthcare·interventional·Posted Jul 29, 2013·Updated Feb 20, 2024

In Brief

A Phase 3 clinical trial evaluating Dolutegravir/abacavir/lamivudine FDC, Atazanavir, and 2 other interventions for Infection, Human Immunodeficiency Virus and HIV Infections. Completed, enrolled 499 participants across 90 sites in 13 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus, HIV Infections
CountriesArgentina, Canada, France, Italy, Mexico, Portugal, Puerto Rico, Russia, South Africa, Spain, Thailand, United Kingdom, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2013
Enrollment StartAug 22, 2013
Primary CompletionSep 22, 2015
Study CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.9 years ago

Interventions

Dolutegravir/abacavir/lamivudine FDCdrug

Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg

Atazanavirdrug

Atazanavir capsule 300 mg

Ritonavirdrug

Ritonavir tablet 100 mg

Tenofovir/emtricitabine FDCdrug

Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC