Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
Public ClinicalTrials.gov record NCT01475838. 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 Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/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 non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination 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
- NCT01475838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 438 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
- Nov 2011 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Jun 8, 2016
2011 – 2014
United States locations
- U.S. sites
- 45
- U.S. states
- 14
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Pueblo Family Physicians | Phoenix | Arizona | 85015 | — |
| AIDS Healthcare Foundation | Beverly Hills | California | 90211 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Kaiser Permanente | Hayward | California | 94545 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Peter J. Ruane, M.D., Inc. | Los Angeles | California | 90036 | — |
| OASIS Clinic | Los Angeles | California | 90043 | — |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| Kaiser Permanente | Sacramento | California | 95841 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94109 | — |
| Kaiser Permanente San Francisco | San Francisco | California | 94118 | — |
| Dupont Circle Physicians Group, P.C | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | — |
| Gary Richmond, MD | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Idocf/Valuhealthmd, Llc | Orlando | Florida | 32806 | — |
| Infectious Diseases Associates of NW FL, P.A. | Pensacola | Florida | 32504 | — |
| AHF Health Positive Tampa Bay | Safety Harbor | Florida | 34695 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| Northwestern University Division of Infectious Diseases | Chicago | Illinois | 60611 | — |
| John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| The Kansas City Free Health Clinic | Kansas City | Missouri | 64111 | — |
| I.D. Care Associates PA | 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 | — |
| ID Consultants, P.A. | Charlotte | North Carolina | 28209 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Uptown Physicians Group | Dallas | Texas | 75204 | — |
| Southwest Infectious Disease Clinical Research, Inc | Dallas | Texas | 75219 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Gordon Crofoot Md, Pa | Houston | Texas | 77098 | — |
| St. Hope Foundation Inc | Houston | Texas | 77401 | — |
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 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01475838, 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 Jun 8, 2016 · Synced Oct 18, 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 NCT01475838 live on ClinicalTrials.gov.