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NCT01797445 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 872
- Enrollment target
NCT01797445: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01797445 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 872 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797445, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 872 participants
- Enrollment target
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) 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.
Interventions
- DRUG E/C/F/TAF
- DRUG E/C/F/TDF
- DRUG E/C/F/TDF Placebo
- DRUG E/C/F/TAF Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 872 participants |
| Start Date | 2013-03-12 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 3 |
What the finished NCT01797445 record still lists
NCT01797445 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 4 interventions - of which E/C/F/TAF is the first listed.
NCT01797445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01797445 about?
NCT01797445 is a clinical study titled "Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF 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) in HIV-1 positive, antiretroviral treatment-n...
What is the current status of trial NCT01797445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 872 participants. The study started on 2013-03-12. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT01797445?
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 NCT01797445?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01797445's enrollment target sits among peer trials
872 373rd of 2000 higher than 1,628 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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