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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 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 722 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02831764
The ClinicalTrials.gov registry entry for NCT02831764 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 722 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dolutegravir (DTG) is the first listed.
NCT02831764 reports 0 study locations.
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.
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