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)
Public ClinicalTrials.gov record NCT01910402. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01910402
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 499 participants
Conditions and interventions
Interventions
- Dolutegravir/abacavir/lamivudine FDC Drug
- Atazanavir Drug
- Ritonavir Drug
- Tenofovir/emtricitabine FDC Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 21, 2013
- Primary completion
- Sep 21, 2015
- Completion
- Aug 17, 2022
- Last update posted
- Feb 19, 2024
2013 – 2022
United States locations
- U.S. sites
- 37
- U.S. states
- 17
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85015 | — |
| GSK Investigational Site | Bakersfield | California | 93301 | — |
| GSK Investigational Site | Beverly Hills | California | 90211 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | — |
| GSK Investigational Site | Miami | Florida | 33133 | — |
| GSK Investigational Site | Orlando | Florida | 32803 | — |
| GSK Investigational Site | Tampa | Florida | 33602 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Augusta | Georgia | 30912-3130 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Savannah | Georgia | 31401 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01199 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | Kansas City | Missouri | 64111 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Omaha | Nebraska | 68198 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89106 | — |
| GSK Investigational Site | Neptune City | New Jersey | 7754 | — |
| GSK Investigational Site | Newark | New Jersey | 07103 | — |
| GSK Investigational Site | Buffalo | New York | 14215 | — |
| GSK Investigational Site | Valhalla | New York | 10595 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27401-1209 | — |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | — |
| GSK Investigational Site | Bellaire | Texas | 77401 | — |
| GSK Investigational Site | Dallas | Texas | 75235 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | El Paso | Texas | 79905 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01910402, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01910402 live on ClinicalTrials.gov.