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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: Completed Phase 4 study, sponsored by Janssen Scientific Affairs.
NCT04442737 is a Phase 4 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 103 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent change from baseline in body weight at Week 24 were reported.
Interventions
- DRUG D/C/F/TAF FDC
- DRUG TAF/FTC FDC
- DRUG INI Based Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2023-08-30 |
| Phase | Phase 4 |
What the finished NCT04442737 record still lists
NCT04442737 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which D/C/F/TAF FDC is the first listed.
NCT04442737 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04442737's enrollment target sits among peer trials
103 760th of 2000 higher than 1,237 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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