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NCT04442737 · ClinicalTrials.gov registry record · Phase 4

A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

A Phase 4 study, sponsored by Janssen Scientific Affairs.

Completed
Registry status
Phase 4
Development phase
103
Enrollment target

NCT04442737 is a Phase 4 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 103 participants.

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The verdict

NCT04442737, a Phase 4 study, has completed, sponsored by Janssen Scientific Affairs.

COMPLETED
Registry status
Phase 4
Development phase
103 participants
Enrollment target

Study Summary

The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.

Interventions

  • DRUG D/C/F/TAF FDC
  • DRUG TAF/FTC FDC
  • DRUG INI Based Regimen

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2020-07-01
Est. Completion 2023-08-30
Phase Phase 4

Sponsor

Janssen Scientific Affairs

37 total trials

What the Registry Record Tells You About NCT04442737

The ClinicalTrials.gov registry entry for NCT04442737 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 103 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 3 interventions - of which D/C/F/TAF FDC is the first listed.

NCT04442737 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04442737 about?

NCT04442737 is a clinical study titled "A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain". The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine...

What is the current status of trial NCT04442737?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2020-07-01. Estimated completion is 2023-08-30.

What interventions are being tested in trial NCT04442737?

The interventions under investigation include: D/C/F/TAF FDC (DRUG), TAF/FTC FDC (DRUG), INI Based Regimen (DRUG).

Who is sponsoring clinical trial NCT04442737?

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.