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NCT01780506 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
A Phase 3 study of HIV Infections and HIV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 872
- Enrollment target
- 20
- Study locations
NCT01780506: Completed Phase 3 study of HIV Infections and HIV, sponsored by Gilead Sciences.
NCT01780506 is a Phase 3 study of HIV Infections and HIV that has completed, run by Gilead Sciences. The registered enrollment target is 872 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (96% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01780506, a Phase 3 study of HIV Infections and HIV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 872 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Primary Outcome
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 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.
Conditions Studied
Interventions
- DRUG E/C/F/TAF
- DRUG E/C/F/TDF
- DRUG E/C/F/TDF Placebo
- DRUG E/C/F/TAF Placebo
Study Locations (20)
California
- Kaiser Permanente Los Angeles - Los Angeles
- University of California, Los Angeles - Los Angeles
- Peter J. Ruane, MD, Inc. - Los Angeles
- Anthony Mills MD Inc - Los Angeles
- East Bay AIDS Center - Oakland
- Kaiser Permanente - Sacramento - Sacramento
- La Playa Medical Group and Clinical Research - San Diego
- University of California, San Diego - San Diego
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Torrance
Florida
- Gary Richmond, MD, PA, Inc. - Fort Lauderdale
- Midway Immunology & Research Center, LLC - Ft. Pierce
- The Kinder Medical Group - Miami
- AIDS Healthcare Foundation - Miami Beach
District of Columbia
- Dupont Circle Physicians Group, P.C. - Washington D.C.
- Whitman Walker Clinic - Washington D.C.
- Capital Medical Associates, P.C. - Washington D.C.
Alabama
- The University of Alabama at Birmingham - Birmingham
Arizona
- Spectrum Medical Group - Phoenix
Colorado
- Apex Research, LLC - Denver
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 872 participants |
| Start Date | 2012-12-26 |
| Est. Completion | 2017-09-06 |
| Phase | Phase 3 |
What the finished NCT01780506 record still lists
NCT01780506 is an interventional study that assigns participants to a tested intervention. The registered 872 participants enrollment target is mid-sized for trials with a published cap, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (96% higher).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which E/C/F/TAF is the first listed.
NCT01780506 names 20 study sites across 7 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01780506 about?
NCT01780506 is a clinical study titled "Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults". The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatme...
What is the current status of trial NCT01780506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 872 participants. The study started on 2012-12-26. Estimated completion is 2017-09-06.
What conditions does trial NCT01780506 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT01780506?
The interventions under investigation include: E/C/F/TAF (DRUG), E/C/F/TDF (DRUG), E/C/F/TDF Placebo (DRUG), E/C/F/TAF Placebo (DRUG).
Who is sponsoring clinical trial NCT01780506?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01780506 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01780506's enrollment target sits among peer trials
872 35th of 542 higher than 508 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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