Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
Public ClinicalTrials.gov record NCT01440569. 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, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
Study identification
- NCT ID
- NCT01440569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 314 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
- Sep 2011 (Type not available)
- Primary completion
- Aug 2012 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Dec 14, 2016
2011 – 2015
United States locations
- U.S. sites
- 48
- U.S. states
- 20
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | — |
| Long Beach Education and Research Consultants, PC | Long Beach | California | 90813 | — |
| Peter J Ruane MD Inc. | Los Angeles | California | 90036 | — |
| Anthony Mills MD Inc | Los Angeles | California | 90069 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Kaiser Permanente Medical Group | Sacramento | California | 95825 | — |
| La Playa Medical Group and Clinical Research | San Diego | California | 92103 | — |
| Metropolis Medical | San Francisco | California | 94109 | — |
| Apex Research LLC | Denver | Colorado | 80220 | — |
| Dupont Circle Physician's Group | Washington D.C. | District of Columbia | 20009 | — |
| Whitman-Walker Health | Washington D.C. | District of Columbia | 20009 | — |
| Gary J. Richmond,M.D., P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34983 | — |
| Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Atlanta ID group | Atlanta | Georgia | 30309 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Mercer University | Macon | Georgia | 31220 | — |
| Hawaii Center for AIDS, University of Hawaii | Honolulu | Hawaii | 96816 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| Johns Hopkins University | Lutherville | Maryland | 21093 | — |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Central West Clinical Research Inc | Saint Louis | Michigan | 63108 | — |
| HIV Program Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Saint Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| North Shore University Hospital / Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Greiger Clinic | Mount Vernon | New York | 10550 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Carolinas Medical Center-Myer's Park Infectious Disease Clinic | Charlotte | North Carolina | 28079 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Health Services | Winston-Salem | North Carolina | 27157 | — |
| University of PA | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| Trinity Health and Wellness Center/AIDS Arms, Inc. | Dallas | Texas | 75208 | — |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | — |
| Tarrant County Infectious Disease | Fort Worth | Texas | 76104 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Gordon Crofoot MD, PA | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | — |
| Swedish Medical Center | Seattle | Washington | 89104 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01440569, 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 14, 2016 · Synced Oct 17, 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 NCT01440569 live on ClinicalTrials.gov.