Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01495702 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
NCT01495702: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01495702 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 439 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495702, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
Study Summary
This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
Primary Outcome
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Interventions
- DRUG FTC/TDF
- DRUG Stribild
- DRUG NNRTI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01495702 record still lists
NCT01495702 is an interventional study that assigns participants to a tested intervention. The registered 439 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which FTC/TDF is the first listed.
NCT01495702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495702 about?
NCT01495702 is a clinical study titled "Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients". This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV...
What is the current status of trial NCT01495702?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2011-12. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01495702?
The interventions under investigation include: FTC/TDF (DRUG), Stribild (DRUG), NNRTI (DRUG).
Who is sponsoring clinical trial NCT01495702?
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 NCT01495702's enrollment target sits among peer trials
439 872nd of 2000 higher than 1,127 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05421663 · 439 participants · Phase 1
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
- NCT06235151 · 439 participants · Phase 3
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
- NCT05114538 · 440 participants · NA
Improving the Part C Early Intervention Service Delivery System for Children with ASD
- NCT05117619 · 440 participants · NA
The HOME Program for Individuals With Traumatic Brain Injury and Family Members
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia