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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05197075
The ClinicalTrials.gov registry entry for NCT05197075 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 508-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (97% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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