Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02831764 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 722
- Enrollment target
NCT02831764: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT02831764 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 722 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02831764, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 722 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analys
Interventions
- DRUG Dolutegravir (DTG)
- DRUG Lamivudine (3TC)
- DRUG Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 722 participants |
| Start Date | 2016-07-18 |
| Est. Completion | 2022-06-29 |
| Phase | Phase 3 |
What the finished NCT02831764 record still lists
NCT02831764 is an interventional study that assigns participants to a tested intervention. The registered 722 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Dolutegravir (DTG) is the first listed.
NCT02831764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02831764 about?
NCT02831764 is a clinical study titled "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)". 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 \...
What is the current status of trial NCT02831764?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 722 participants. The study started on 2016-07-18. Estimated completion is 2022-06-29.
What interventions are being tested in trial NCT02831764?
The interventions under investigation include: Dolutegravir (DTG) (DRUG), Lamivudine (3TC) (DRUG), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC) (DRUG).
Who is sponsoring clinical trial NCT02831764?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02831764's enrollment target sits among peer trials
722 494th of 2000 higher than 1,507 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06116149 · 722 participants · NA
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
- NCT06641466 · 723 participants · Phase 3
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
- NCT07088068 · 723 participants · Phase 3
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
- NCT06664619 · 724 participants · Phase 3
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI