Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
Public ClinicalTrials.gov record NCT00708162. 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 Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).
Study identification
- NCT ID
- NCT00708162
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 724 participants
Conditions and interventions
Conditions
Interventions
- Elvitegravir Drug
- Raltegravir Drug
- EVG placebo Drug
- RAL placebo Drug
- Background regimen 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
- Jul 2008 (Type not available)
- Primary completion
- Dec 2010 (Actual)
- Completion
- Apr 2015 (Actual)
- Last update posted
- May 30, 2016
2008 – 2015
United States locations
- U.S. sites
- 94
- U.S. states
- 23
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Center for HIV/AIDS | Phoenix | Arizona | 85006 | — |
| Health for Life Clinic, PLLC | Little Rock | Arkansas | 72207 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| AIDS Healthcare Foundation-Research Center | Beverly Hills | California | 90804 | — |
| Center for Special Immunology | Fountain Valley | California | 92708 | — |
| The Living Hope Foundation | Long Beach | California | 90813 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Jeffrey Goodman Special Care Clinic | Los Angeles | California | 90028 | — |
| University of Southern California, AIDS Clinical Trials Unit | Los Angeles | California | 90033 | — |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | — |
| Tony 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 | — |
| Kaiser Permanente | Sacramento | California | 95825 | — |
| David J. Shamblaw, MD Inc. | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94115 | — |
| San Francisco VA Medical Center/UCSF | San Francisco | California | 94121 | — |
| Connecticut Health Care Group | Glastonbury | Connecticut | 06033 | — |
| Circle Medical LLC | Norwalk | Connecticut | 06851 | — |
| The Stamford Hospital - Stamford ID | Stamford | Connecticut | 06902 | — |
| Whitman-Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| South Florida Clinical Research | Atlantis | Florida | 33462 | — |
| Lifeway , Inc. | Fort Lauderdale | Florida | 33308 | — |
| NorthPoint Medical | Fort Lauderdale | Florida | 33308 | — |
| Therafirst Medical Centers | Fort Lauderdale | Florida | 33308 | — |
| Broward Health CCC | Fort Lauderdale | Florida | 33311 | — |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Associates In Infectious Diseases | Ft. Pierce | Florida | 34952 | — |
| The Kinder Medical Group | Miami | Florida | 33133 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Wohlfeiler, Piperato and Associates, LLC | North Miami Beach | Florida | 33169 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Infectious Disease of Central Florida | Orlando | Florida | 32806 | — |
| Barry M. Rodwick, M. D. | Safety Harbor | Florida | 34695 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| The Emory Clinic, Inc., Division of Infectious Diseases | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group | Atlanta | Georgia | 30309 | — |
| Infectious Disease Specialists of Atlanta (IDSA) | Decatur | Georgia | 30033 | — |
| Mercer Univ. School of Medicine | Macon | Georgia | 31201 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| Hawaii AIDS Clinical Research Program HACRP | Honolulu | Hawaii | 96316 | — |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| University of Kentucky Healthcare/Bluegrass Care Clinic | Lexington | Kentucky | 40536 | — |
| University of Maryland, Institute of Human Virology | Baltimore | Maryland | 21201 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital Div of Infectious Disease | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice | Newark | New Jersey | 07103 | — |
| South Jersey Infectious Disease | Somer Point | New Jersey | 08244 | — |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| STAR Health Care Center | Brooklyn | New York | 11203 | — |
| 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 | — |
| Ricky K. Hsu, MD, PC | New York | New York | 10011 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| AIDS Community HealthCenter | Rochester | New York | 14604 | — |
| Montefiore Medical Center | The Bronx | New York | 10573 | — |
| University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit | Chapel Hill | North Carolina | 27514 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28207 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Brody School of Medicine at 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 CARE Center | Akron | Ohio | 44304 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Jefferson Alumni Hall | Philadelphia | Pennsylvania | 19107 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| AIDS Arms/ Peabody Health Center | Dallas | Texas | 75215 | — |
| Southwest Infectious Disease Clinical Research | Dallas | Texas | 75219 | — |
| Presbyterian Hospital of Dallas | Dallas | Texas | 75231 | — |
| North Texas Infectious Disease Consultants | Dallas | Texas | 75246 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Garcia Family Health Group | Harlingen | Texas | 78550 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | — |
| The Schrader Clinic | Houston | Texas | 77098 | — |
| Joseph C. Gathe, JR. MD, F.A.C.P. | Houston | Texas | 77478 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | — |
| EHS Pulmonary and Critical Care | Spokane | Washington | 99204 | — |
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 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00708162, 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 30, 2016 · Synced Oct 22, 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 NCT00708162 live on ClinicalTrials.gov.