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NCT05197075 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
A Phase 1 study of Human Immunodeficiency Virus (HIV), sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 6
- Study locations
NCT05197075: Completed Phase 1 study of Human Immunodeficiency Virus (HIV), sponsored by Janssen Research & Development.
NCT05197075 is a Phase 1 study of Human Immunodeficiency Virus (HIV) that has completed, run by Janssen Research & Development. The registered enrollment target is 15 participants, below the 508-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05197075, a Phase 1 study of Human Immunodeficiency Virus (HIV), has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.
Primary Outcome
The percentage of participants that is able to swallow the medication fully versus partially or not at all, based on the questionnaire for the observer will be reported.
Conditions Studied
Interventions
- DRUG DRV/COBI FDC
Study Locations (6)
Other
- Rahima Moosa Mother and Child Hospital, University of Witwatersrand - Johannesburg
- Global Clinical Trials PE - Pretoria
- Hosp. Gral. Univ. Gregorio Maranon - Madrid
- Hosp. Clinico San Carlos - Madrid
- Hosp. Univ. La Paz - Madrid
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2022-09-23 |
| Phase | Phase 1 |
What the finished NCT05197075 record still lists
NCT05197075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 508-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 1 intervention - of which DRV/COBI FDC is the first listed.
NCT05197075 lists 6 locations in 2 states (Other, Georgia).
Frequently Asked Questions
What is clinical trial NCT05197075 about?
NCT05197075 is a clinical study titled "A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children". The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.
What is the current status of trial NCT05197075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-08-03. Estimated completion is 2022-09-23.
What conditions does trial NCT05197075 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV).
What interventions are being tested in trial NCT05197075?
The interventions under investigation include: DRV/COBI FDC (DRUG).
Who is sponsoring clinical trial NCT05197075?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05197075 being conducted?
This trial has 6 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus (HIV)
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Where NCT05197075's enrollment target sits among peer trials
15 17th of 18 higher than 2 of 18 other Human Immunodeficiency Virus (HIV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus (HIV) 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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