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NCT02600819 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
- 20
- Study locations
NCT02600819: Completed Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT02600819 is a Phase 3 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 55 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02600819, a Phase 3 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
Primary Outcome
Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events
Conditions Studied
Interventions
- DRUG B/F/TAF
- DRUG E/C/F/TAF
Study Locations (20)
Florida
- Midway Immunology & Research Center, LLC - Ft. Pierce
- Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center - Orlando
- Triple O Research Institute PA - West Palm Beach
Georgia
- Medical College of Georgia - Augusta
- Infectious Disease Specialists of Atlanta - Decatur
- Mercer University School of Medicine - Macon
North Carolina
- University of North Carolina at Chapel Hill / UNC School of Medicine - Chapel Hill
- Duke University - Durham
- Wake Forest University Baptist Medical Center - Winston-Salem
Texas
- North Texas Infectious Diseases Consultants - Dallas
- Trinity Health and Wellness Center - Fort Worth
- Gordon E. Crofoot MD PA - Houston
California
- Peter J Ruane MD Inc - Los Angeles
- University of California Davis - Sacramento
Ohio
- University of Cincinnati Med Center - Cincinnati
- MetroHealth Medical Center IRB - Cleveland
Massachusetts
- The Research Institute - Springfield
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-12-14 |
| Est. Completion | 2019-10-15 |
| Phase | Phase 3 |
What the finished NCT02600819 record still lists
NCT02600819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (84% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which B/F/TAF is the first listed.
NCT02600819 names 20 study sites across 10 states, led by Florida, Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02600819 about?
NCT02600819 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis". The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (...
What is the current status of trial NCT02600819?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2015-12-14. Estimated completion is 2019-10-15.
What conditions does trial NCT02600819 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT02600819?
The interventions under investigation include: B/F/TAF (DRUG), E/C/F/TAF (DRUG).
Who is sponsoring clinical trial NCT02600819?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02600819 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02600819's enrollment target sits among peer trials
55 46th of 71 higher than 26 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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