Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Public ClinicalTrials.gov record NCT01106586. 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, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
Study identification
- NCT ID
- NCT01106586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 708 participants
Conditions and interventions
Conditions
Interventions
- Stribild Drug
- ATV Drug
- Ritonavir Drug
- FTC/TDF Drug
- Stribild Placebo Drug
- ATV Placebo Drug
- RTV Placebo Drug
- FTC/TDF Placebo Drug
Drug
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
- Apr 2010 (Type not available)
- Primary completion
- Sep 2011 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Nov 11, 2015
2010 – 2014
United States locations
- U.S. sites
- 86
- U.S. states
- 23
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Health for Life Clinic PLLC | Little Rock | Arkansas | 72207 | — |
| AHF Research Center | Beverly Hills | California | 90211 | — |
| CSI Clinical Trials, Inc. | Costa Mesa | California | 92626 | — |
| Apex Research, LLC | Denver | California | 80209 | — |
| Kaiser Permanente Hospital | Hayward | California | 94545 | — |
| Living Hope Clinical Foundation | Long Beach | California | 90813 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90028 | — |
| Peter J Ruane, MD, Inc | Los Angeles | California | 90036 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Anthony Mills MD Inc | 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 Medical Center | Sacramento | California | 95817 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolitan Medical | San Francisco | California | 94115 | — |
| Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California | 94118 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Yale University HIV Clinical Trials Program | New Haven | Connecticut | 06033 | — |
| The Stamford Hospital | Stamford | Connecticut | 06902 | — |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| Capital Medical Associates, PC | Washington D.C. | District of Columbia | 20036 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Broward Health/Comprehensive Care Center | Fort Lauderdale | Florida | 33311 | — |
| Gary J. Richmond,M.D., P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| IDOCF/ ValueHealthMD, LLC | Orlando | Florida | 32806 | — |
| University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | Tampa | Florida | 33602 | — |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33615 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Infectious Disease Solutions, PC | Atlanta | Georgia | 30309 | — |
| Mercer University School of Medicine | Macon | Georgia | 31210 | — |
| Leahi Hospital | Honolulu | Hawaii | 96816 | — |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| The Research Institute | Springfield | Massachusetts | 01107 | — |
| Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts | 01199 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| CentralWest Clinical Research | St Louis | Missouri | 63108 | — |
| Division of Infectious Diseases, St. Louis University Medical Center | St Louis | Missouri | 63110 | — |
| Southampton Healthcare | St Louis | Missouri | 63139 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Garden State Infectious Diseases Associates, PA | Voorhees Township | New Jersey | 08043 | — |
| Upstate ID Association | Albany | New York | 12208 | — |
| Albany Medical College | Albany | New York | 12209 | — |
| STAR Health Care Center (SUNY Downstate) | Brooklyn | New York | 11203 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Greiger Clinic | Mount Vernon | New York | 10550 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Chelsea Village Medical, PC | New York | New York | 10011 | — |
| AIDS Care | Rochester | New York | 14604 | — |
| Montiefiore Medical Center- AIDS Center | The Bronx | New York | 10467 | — |
| Carolinas Medical Center-Myers Park | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| Division of Infectious Diseases, Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| University of South Carolina | Columbia | South Carolina | 29203 | — |
| Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.) | Dallas | Texas | 75204 | — |
| Trinity Health and Wellness Center/AIDS Arms, Inc. | Dallas | Texas | 75208 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Garcia's Family Health Group | Harlingen | Texas | 78550 | — |
| Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA) | 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 (CARE-ID) | Annandale | Virginia | 22003 | — |
| Peter Shalit, M.D. | Seattle | Washington | 98104 | — |
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 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01106586, 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 Nov 11, 2015 · Synced Oct 23, 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 NCT01106586 live on ClinicalTrials.gov.