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NCT02993237 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02993237: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02993237 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02993237, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.
Primary Outcome
Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.
Interventions
- DRUG DRV/COBI FDC placebo tablet
- DRUG D/C/F/TAF FDC placebo tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-01-23 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 1 |
What the finished NCT02993237 record still lists
NCT02993237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which DRV/COBI FDC placebo tablet is the first listed.
NCT02993237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02993237 about?
NCT02993237 is a clinical study titled "Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets". The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 i...
What is the current status of trial NCT02993237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-01-23. Estimated completion is 2017-05-25.
What interventions are being tested in trial NCT02993237?
The interventions under investigation include: DRV/COBI FDC placebo tablet (DRUG), D/C/F/TAF FDC placebo tablets (DRUG).
Who is sponsoring clinical trial NCT02993237?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02993237's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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