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NCT02397694 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
98
Enrollment target

NCT02397694 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 98 participants.

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The verdict

NCT02397694, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
98 participants
Enrollment target

Study Summary

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Interventions

  • DRUG F/TAF
  • DRUG DTG
  • DRUG DTG Placebo
  • DRUG BIC
  • DRUG BIC Placebo

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2015-03-23
Est. Completion 2019-02-27
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT02397694

The ClinicalTrials.gov registry entry for NCT02397694 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 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 F/TAF is the first listed.

NCT02397694 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02397694 about?

NCT02397694 is a clinical study titled "Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults". This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic...

What is the current status of trial NCT02397694?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2015-03-23. Estimated completion is 2019-02-27.

What interventions are being tested in trial NCT02397694?

The interventions under investigation include: F/TAF (DRUG), DTG (DRUG), DTG Placebo (DRUG), BIC (DRUG), BIC Placebo (DRUG).

Who is sponsoring clinical trial NCT02397694?

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.