Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
Public ClinicalTrials.gov record NCT01252940. 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 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
Study identification
- NCT ID
- NCT01252940
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 482 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 2010 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Dec 4, 2015
2010 – 2014
United States locations
- U.S. sites
- 66
- U.S. states
- 20
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | — |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Health for Life Clinic, PLLC | Little Rock | Arkansas | 72207 | — |
| AIDS Healthcare Foundation-Research Center | Beverly Hills | California | 90211 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | — | — |
| Center for Special Immunology | Costa Mesa | California | 92626 | — |
| Kaiser Permanente | Hayward | California | 94545 | — |
| The Living Hope Foundation | Long Beach | California | 90813 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90019 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90028 | — |
| Oasis Clinic | Los Angeles | California | 90059 | — |
| Anthony Mills, MD Internal Medicine | Los Angeles | California | 90069 | — |
| Orange Coast Medical Group | Newport Beach | California | 92663 | — |
| Alameda County Medical Center | Oakland | California | 94602 | — |
| East Bay AIDS Center | Oakland | California | 94609 | — |
| Stanford University | Palo Alto | California | 94303 | — |
| University of California, Davis | Sacramento | California | 95187 | — |
| Kaiser Permanente | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94115 | — |
| Kaiser Permanente | San Francisco | California | 94118 | — |
| Capital Medical Associates PC | Washington D.C. | District of Columbia | 20036 | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology & Research Center | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| Care Resource | Miami | Florida | — | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| ValueHealthMD, LLC/IDOCF | Orlando | Florida | 32806 | — |
| Wade, Barbara Private Practice | Pensacola | Florida | 32504 | — |
| Barry M. Rodwick, M.D. | Safety Harbor | Florida | 34695 | — |
| University of South Florida - HIV Clinical Research Unit | Tampa | Florida | 33062 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| Infectious Disease Specialists of Atlanta (IDSA) | Decatur | Georgia | 30033 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| Johns Hopkins University School of Medicine | Lutherville | Maryland | 21093 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Kansas City Free Health Clinic | Kansas City | Missouri | — | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somer Point | New Jersey | 08244 | — |
| Greiger Clinic | Mount Vernon | New York | — | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| The Aaron Diamond AIDS Research Center | New York | New York | 10016 | — |
| ID Consultant, P.A. | Charlotte | North Carolina | 28209 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| University of South Carolina | Columbia | South Carolina | 29203 | — |
| Nicholaos Bellos, MD, PA | Dallas | Texas | 75204 | — |
| Tarrant County Infectious Diseases Associates | Fort Worth | Texas | 76104 | — |
| Garcia Family Medical Clinic | Harlingen | Texas | 78550 | — |
| Therapeutic Concepts, P.A. | Houston | Texas | 77004 | — |
| Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | — |
| Research Access Network | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Clinical Alliance for Research & Education-Infectious Diseases, LLC (CARE-ID) | 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 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01252940, 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 Dec 4, 2015 · Synced Oct 21, 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 NCT01252940 live on ClinicalTrials.gov.