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NCT03110380 · ClinicalTrials.gov registry record · Phase 3
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 567
- Enrollment target
NCT03110380: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT03110380 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 567 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03110380, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 567 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
Primary Outcome
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Interventions
- DRUG B/F/TAF
- DRUG F/TAF
- DRUG F/TAF Placebo
- DRUG DTG
- DRUG DTG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2021-02-10 |
| Phase | Phase 3 |
What the finished NCT03110380 record still lists
NCT03110380 is an interventional study that assigns participants to a tested intervention. The registered 567 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which B/F/TAF is the first listed.
NCT03110380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03110380 about?
NCT03110380 is a clinical study titled "Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed". The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/teno...
What is the current status of trial NCT03110380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 567 participants. The study started on 2017-06-12. Estimated completion is 2021-02-10.
What interventions are being tested in trial NCT03110380?
The interventions under investigation include: B/F/TAF (DRUG), F/TAF (DRUG), F/TAF Placebo (DRUG), DTG (DRUG), DTG Placebo (DRUG).
Who is sponsoring clinical trial NCT03110380?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03110380's enrollment target sits among peer trials
567 667th of 2000 higher than 1,334 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
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