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Antiretroviral

D/C/F/TAF FDC for HIV (DEFINE Trial)

Phase 4
Waitlist Available
Research Sponsored by Janssen Scientific Affairs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 12, 24, 36 and 48
Awards & highlights

DEFINE Trial Summary

This trial will study whether switching to a different HIV medication will help people who have experienced rapid and significant weight gain.

Eligible Conditions
  • HIV

DEFINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 12, 24, 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 12, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change from Baseline in Body Weight at Week 24
Secondary outcome measures
Adherence Rate to Treatment at Weeks 4, 12 and 24
Association Between Treatment Arm and Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Week 24
Change from Baseline in Absolute Body Weight at Weeks 24 and 48
+37 more

DEFINE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: D/C/F/TAF FDC Arm (Immediate Switch)Experimental Treatment1 Intervention
Participants will be immediately switched to a regimen of darunavir 800 milligram (mg)/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily for 48 weeks.
Group II: INI + TAF/FTC Arm (Delayed Switch)Active Control3 Interventions
Participants will continue to receive current baseline integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen for 24 weeks. After 24 weeks participants will switch to a regimen of D/C/F/TAF FDC once daily for an additional 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D/C/F/TAF FDC
2020
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCLead Sponsor
159 Previous Clinical Trials
580,415 Total Patients Enrolled
Janssen Scientific Affairs, LLC Clinical TrialStudy DirectorJanssen Scientific Affairs, LLC
36 Previous Clinical Trials
86,135 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently enlisting participants?

"Data on clinicaltrials.gov confirms that this research initiative, which originated on July 1st 2020, is not currently enrolling participants. Nevertheless, there are 71 other studies actively seeking patients at the moment."

Answered by AI

How detrimental is the D/C/F/TAF FDC drug regimen to individuals?

"It is accepted that the safety of D/C/F/TAF FDC warrants a score of 3, given it has reached Phase 4 status and been approved."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Saint Michael's Medical Center - Infectious Disease
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long will the intake be?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I want to help with the research.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04442737.
~21 spots leftby May 2025
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