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NCT04006704 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
A Phase 1 study of HIV-1, sponsored by Janssen Pharmaceutica N.V., Belgium.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 8
- Study locations
NCT04006704: Completed Phase 1 study of HIV-1, sponsored by Janssen Pharmaceutica N.V., Belgium.
NCT04006704 is a Phase 1 study of HIV-1 that has completed, run by Janssen Pharmaceutica N.V., Belgium. The registered enrollment target is 25 participants, below the 134-participant average among 9 other HIV-1 trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04006704, a Phase 1 study of HIV-1, has completed, sponsored by Janssen Pharmaceutica N.V., Belgium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 8
- Study locations
Study Summary
The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
Primary Outcome
Ability to swallow the scored film-coated tablet irrespective of mode of intake (whole or split tablet) will be assessed.
Conditions Studied
Interventions
- DRUG D/C/F/TAF FDC placebo
Study Locations (8)
Other
- Hosp. Sant Joan de Deu - Esplugues de Llobregat
- Hosp. Gral. Univ. Gregorio Marañon - Madrid
- Hosp. Univ. 12 de Octubre - Madrid
- Hosp. Univ. La Paz - Madrid
Arizona
- Phoenix Children's Hospital - Phoenix
Georgia
- Emory University - Atlanta
Tennessee
- St Jude Children's Research Hospital - Memphis
Texas
- University of Texas Health Science Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 1 |
What the finished NCT04006704 record still lists
NCT04006704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 134-participant average among 9 other HIV-1 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 1 intervention - of which D/C/F/TAF FDC placebo is the first listed.
NCT04006704 lists 8 locations in 5 states (Other, Arizona, Georgia).
Frequently Asked Questions
What is clinical trial NCT04006704 about?
NCT04006704 is a clinical study titled "Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets". The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
What is the current status of trial NCT04006704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-10-10. Estimated completion is 2020-03-06.
What conditions does trial NCT04006704 study?
This clinical trial studies the following conditions: HIV-1.
What interventions are being tested in trial NCT04006704?
The interventions under investigation include: D/C/F/TAF FDC placebo (DRUG).
Who is sponsoring clinical trial NCT04006704?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04006704 being conducted?
This trial has 8 study locations across Arizona, Georgia, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04006704's enrollment target sits among peer trials
25 9th of 9 higher than 1 of 9 other HIV-1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1 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.
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