Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Public ClinicalTrials.gov record NCT01108510. 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 GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With 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.
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.
Study identification
- NCT ID
- NCT01108510
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 698 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
- Apr 2010 (Type not available)
- Primary completion
- Nov 2011 (Actual)
- Completion
- Apr 2015 (Actual)
- Last update posted
- May 23, 2016
2010 – 2015
United States locations
- U.S. sites
- 64
- U.S. states
- 23
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Health for Life Clinic PLLC | Little Rock | Arkansas | 72207 | — |
| 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 | — |
| Oasis Clinic | Los Angeles | California | 90059 | — |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | — |
| 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 | — |
| Metropolis Medical | San Francisco | California | 94115 | — |
| Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California | 94118 | — |
| Apex Research, LLC | Denver | Colorado | 80220 | — |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman-Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| 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 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Idocf/ Valuhealthmd, 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 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University School of Medicine | Macon | Georgia | 31210 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| 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 | — |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| SouthWest CARE Center | Santa Fe | New Mexico | 87505 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Chelsea Village Medical, PC | New York | New York | 10011 | — |
| Mt Sinai School of Medicine | New York | New York | 10011 | — |
| Ricky K. Hsu, MD, PC | New York | New York | 10011 | — |
| Montefiore 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, The Brody School of Medicine | Greenville | North Carolina | 27834 | — |
| Rosedale Infectious Diseases | Huntersville | North Carolina | 28078 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Division of Infectious Diseases, Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| University of South Carolina | Columbia | South Carolina | 29203 | — |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75204 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Garcia's Family Health Group | Harlingen | Texas | 78550 | — |
| 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 | — |
| Peter Shalit, M.D. | Seattle | Washington | 98104 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01108510, 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 May 23, 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 NCT01108510 live on ClinicalTrials.gov.