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NCT01497899 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 279
- Enrollment target
NCT01497899: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT01497899 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 279 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497899, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 279 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
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
- DRUG E/C/F/TDF
- DRUG E/C/F/TDF Placebo
- DRUG E/C/F/TAF Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2011-12-28 |
| Est. Completion | 2016-08-22 |
| Phase | Phase 2 |
What the finished NCT01497899 record still lists
NCT01497899 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 4 interventions - of which E/C/F/TAF is the first listed.
NCT01497899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497899 about?
NCT01497899 is a clinical study titled "Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults". The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, a...
What is the current status of trial NCT01497899?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2011-12-28. Estimated completion is 2016-08-22.
What interventions are being tested in trial NCT01497899?
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 NCT01497899?
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 NCT01497899's enrollment target sits among peer trials
279 201st of 2000 higher than 1,799 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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