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
Public ClinicalTrials.gov record NCT01495702. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01495702
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 439 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2011 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Jan 7, 2016
2011 – 2014
United States locations
- U.S. sites
- 39
- U.S. states
- 14
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| AHF Research Center | Beverly Hills | California | 90211 | — |
| Pacific Oak Medical Group | Beverly Hills | California | 90211 | — |
| Kaiser Permanente | Hayward | California | 94545 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| OASIS Clinic | Los Angeles | California | 90059 | — |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | — |
| Alameda County Medical Center | Oakland | California | 94602 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94109 | — |
| Kaiser Permanente | San Francisco | California | 94118 | — |
| Dupont Circle Physicians Group, P.C. | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates, P.C. | Washington D.C. | District of Columbia | 20036 | — |
| Gary Richmond MD, PA, Inc | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| ValuHealth MD, LLC | Orlando | Florida | 32806 | — |
| Infectious Diseases Associates of Northwest Florida | Pensacola | Florida | 32504 | — |
| Health Positive | Safety Harbor | Florida | 34684 | — |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| HIV Program Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| The Kansas City Free Health Clinic | Kansas City | Missouri | 64111 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Greiger Clinic | Mount Vernon | New York | 10550 | — |
| Aaron Diamond AIDS Research Center | New York | New York | 10016 | — |
| ID Consultants, P.A. | Charlotte | North Carolina | 28209 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Southwest Infectious Disease Clinical Researach Inc | Dallas | Texas | 75219 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts PA | Houston | Texas | 77004 | — |
| Gordon E. Crofoot MD, PA | Houston | Texas | 77098 | — |
| Clinical Alliance for Research & Education - Infectious Disease | Annandale | Virginia | 22003 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01495702, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2016 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01495702 live on ClinicalTrials.gov.