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NCT02071082 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
A Phase 3 study of HIV and HBV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT02071082: Completed Phase 3 study of HIV and HBV, sponsored by Gilead Sciences.
NCT02071082 is a Phase 3 study of HIV and HBV that has completed, run by Gilead Sciences. The registered enrollment target is 79 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02071082, a Phase 3 study of HIV and HBV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive * Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
Primary Outcome
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Interventions
- DRUG E/C/F/TAF
Study Locations (20)
Florida
- Barry M. Rodwick MD - Clearwater
- Gary J Richmond M.D.,P.A. - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- AIDS Health Foundation/WPA - Miami Beach
- AIDS Research and Treatment Center of the Treasure Coast - Vero Beach
- Triple O Research Institute PA - West Palm Beach
Texas
- Central Texas Clinical Research - Austin
- St. Hope Foundation - Bellaire
- North Texas Infectious Diseases Consultants - Dallas
- Therapeutic Concepts - Houston
- Gordon E. Crofoot MD PA - Houston
California
- AHF Research Center - Beverly Hills
- Peter J. Ruane MD, Inc. - Los Angeles
- Anthony Mills MD, Inc - Los Angeles
Missouri
- KC Care Clinic - Kansas City
- Southampton Healthcare, Inc. - St Louis
Arizona
- Spectrum Medical Group - Phoenix
District of Columbia
- Whitman Walker Health - Washington D.C.
Michigan
- Be Well Medical Center PC - Berkley
New Mexico
- Southwest CARE Center - Santa Fe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-02-25 |
| Est. Completion | 2016-10-26 |
| Phase | Phase 3 |
What the finished NCT02071082 record still lists
NCT02071082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention - of which E/C/F/TAF is the first listed.
NCT02071082 names 20 study sites across 8 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT02071082 about?
NCT02071082 is a clinical study titled "Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults". This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * C...
What is the current status of trial NCT02071082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2014-02-25. Estimated completion is 2016-10-26.
What conditions does trial NCT02071082 study?
This clinical trial studies the following conditions: HIV, HBV.
What interventions are being tested in trial NCT02071082?
The interventions under investigation include: E/C/F/TAF (DRUG).
Who is sponsoring clinical trial NCT02071082?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02071082 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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79 181st of 303 higher than 122 of 303 other HIV trials
participants (enrollment target), bucketed by value
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