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NCT02269917 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
A Phase 3 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,149
- Enrollment target
NCT02269917: Completed Phase 3 study, sponsored by Janssen R&D Ireland.
NCT02269917 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 1,149 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02269917, a Phase 3 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,149 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid \[HIV-1 RNA\] concentrations less than \[\<\] 50 copies per milliliter \[copies/mL\]) HIV-1 infected participants.
Primary Outcome
Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (\>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
Interventions
- DRUG FTC/TDF
- DRUG D/C/F/TAF
- DRUG Boosted Protease Inhibitor (bPI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,149 participants |
| Start Date | 2015-03 |
| Est. Completion | 2020-10 |
| Phase | Phase 3 |
What the finished NCT02269917 record still lists
NCT02269917 is an interventional study that assigns participants to a tested intervention. Its 1,149 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 3 interventions - of which FTC/TDF is the first listed.
NCT02269917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02269917 about?
NCT02269917 is a clinical study titled "Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants". The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a ...
What is the current status of trial NCT02269917?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,149 participants. The study started on 2015-03. Estimated completion is 2020-10.
What interventions are being tested in trial NCT02269917?
The interventions under investigation include: FTC/TDF (DRUG), D/C/F/TAF (DRUG), Boosted Protease Inhibitor (bPI) (DRUG).
Who is sponsoring clinical trial NCT02269917?
This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02269917's enrollment target sits among peer trials
1,149 242nd of 2000 higher than 1,759 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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