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NCT02121795 · ClinicalTrials.gov registry record · Phase 3

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
668
Enrollment target

NCT02121795 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 668 participants.

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The verdict

NCT02121795, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
668 participants
Enrollment target

Study Summary

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

Interventions

  • DRUG FTC/TDF
  • DRUG F/TAF
  • DRUG F/TAF Placebo
  • DRUG FTC/TDF Placebo
  • DRUG Allowed third antiretroviral agent

Trial Details

FieldValue
Enrollment Target 668 participants
Start Date 2014-05-06
Est. Completion 2019-03-01
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT02121795

The ClinicalTrials.gov registry entry for NCT02121795 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 668 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.

NCT02121795 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02121795 about?

NCT02121795 is a clinical study titled "Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF". This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study wi...

What is the current status of trial NCT02121795?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2014-05-06. Estimated completion is 2019-03-01.

What interventions are being tested in trial NCT02121795?

The interventions under investigation include: FTC/TDF (DRUG), F/TAF (DRUG), F/TAF Placebo (DRUG), FTC/TDF Placebo (DRUG), Allowed third antiretroviral agent (DRUG).

Who is sponsoring clinical trial NCT02121795?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.