An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
Public ClinicalTrials.gov record NCT02831764. 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 III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate \[TDF\]/emtricitabine \[FTC\] fixed dose combination \[FDC\]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult participants that have not previously received antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 participants will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.
Study identification
- NCT ID
- NCT02831764
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 722 participants
Conditions and interventions
Interventions
- Dolutegravir (DTG) Drug
- Lamivudine (3TC) Drug
- Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Jul 17, 2016
- Primary completion
- Apr 3, 2018
- Completion
- Jun 28, 2022
- Last update posted
- Dec 6, 2023
2016 – 2022
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294-3300 | — |
| GSK Investigational Site | Los Angeles | California | 90069 | — |
| GSK Investigational Site | Sacramento | California | 95825 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | San Leandro | California | 94577 | — |
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20005 | — |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | — |
| GSK Investigational Site | Miami | Florida | 33133 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Orlando | Florida | 32803 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Savannah | Georgia | 31401 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Berkley | Michigan | 48072 | — |
| GSK Investigational Site | St Louis | Missouri | 63139 | — |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | — |
| GSK Investigational Site | Newark | New Jersey | 07102 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77009 | — |
| GSK Investigational Site | Houston | Texas | 77098 | — |
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 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02831764, 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 Dec 6, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02831764 live on ClinicalTrials.gov.