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NCT01968551 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT01968551 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 158 participants.
The verdict
NCT01968551, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 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) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
Interventions
- DRUG DRV
- DRUG E/C/F/TAF
- DRUG Baseline DRV- containing ARV regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2013-09-03 |
| Est. Completion | 2016-07-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01968551
The ClinicalTrials.gov registry entry for NCT01968551 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which DRV is the first listed.
NCT01968551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01968551 about?
NCT01968551 is a clinical study titled "Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive 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) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with...
What is the current status of trial NCT01968551?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2013-09-03. Estimated completion is 2016-07-09.
What interventions are being tested in trial NCT01968551?
The interventions under investigation include: DRV (DRUG), E/C/F/TAF (DRUG), Baseline DRV- containing ARV regimen (DRUG).
Who is sponsoring clinical trial NCT01968551?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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