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NCT02345226 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
881
Enrollment target

NCT02345226: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT02345226 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 881 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02345226, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
881 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Primary Outcome

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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 EFV/FTC/TDF
  • DRUG FTC/RPV/TAF
  • DRUG EFV/FTC/TDF Placebo
  • DRUG FTC/RPV/TAF Placebo

Trial Details

FieldValue
Enrollment Target 881 participants
Start Date 2015-01-26
Est. Completion 2019-01-02
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT02345226 record still lists

NCT02345226 is an interventional study that assigns participants to a tested intervention. The registered 881 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).

The record links to 0 conditions, and to 4 interventions - of which EFV/FTC/TDF is the first listed.

NCT02345226 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02345226 about?

NCT02345226 is a clinical study titled "Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults". The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir d...

What is the current status of trial NCT02345226?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 881 participants. The study started on 2015-01-26. Estimated completion is 2019-01-02.

What interventions are being tested in trial NCT02345226?

The interventions under investigation include: EFV/FTC/TDF (DRUG), FTC/RPV/TAF (DRUG), EFV/FTC/TDF Placebo (DRUG), FTC/RPV/TAF Placebo (DRUG).

Who is sponsoring clinical trial NCT02345226?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02345226's enrollment target sits among peer trials

881 367th of 2000 higher than 1,634 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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Source: ClinicalTrials.gov NCT02345226, the US trial registry maintained by the National Library of Medicine. NCT02345226 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.