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NCT03227861 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
A Phase 3 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
NCT03227861: Completed Phase 3 study, sponsored by Janssen Scientific Affairs.
NCT03227861 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03227861, a Phase 3 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
Primary Outcome
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
Interventions
- DRUG DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 3 |
What the finished NCT03227861 record still lists
NCT03227861 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC is the first listed.
NCT03227861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03227861 about?
NCT03227861 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care". The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined b...
What is the current status of trial NCT03227861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2017-07-31. Estimated completion is 2019-09-04.
What interventions are being tested in trial NCT03227861?
The interventions under investigation include: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC (DRUG).
Who is sponsoring clinical trial NCT03227861?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03227861's enrollment target sits among peer trials
109 1664th of 2000 higher than 337 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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