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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 is a Phase 3 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 109 participants.

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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.

Interventions

  • DRUG DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2017-07-31
Est. Completion 2019-09-04
Phase Phase 3

Sponsor

Janssen Scientific Affairs

37 total trials

What the Registry Record Tells You About NCT03227861

The ClinicalTrials.gov registry entry for NCT03227861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.

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 reports 0 study locations.

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.

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.