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NCT01440569 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
A Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
- 20
- Study locations
NCT01440569: Completed Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, sponsored by Gilead Sciences.
NCT01440569 is a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome that has completed, run by Gilead Sciences. The registered enrollment target is 314 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01440569, a Phase 3 study of HIV Infections and Acquired Immunodeficiency Syndrome, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG DRV
- DRUG NRTIs
- DRUG COBI
Study Locations (20)
California
- Long Beach Education and Research Consultants, PC - Long Beach
- Peter J Ruane MD Inc. - Los Angeles
- Anthony Mills MD Inc - Los Angeles
- Stanford University - Palo Alto
- Kaiser Permanente Medical Group - Sacramento
- La Playa Medical Group and Clinical Research - San Diego
- Metropolis Medical - San Francisco
Florida
- Gary J. Richmond,M.D., P.A. - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- Wohlfeiler, Piperato and Associates, LLC - Miami Beach
- Orlando Immunology Center - Orlando
- St. Joseph's Comprehensive Research Institute - Tampa
Georgia
- Atlanta ID group - Atlanta
- Infectious Disease Specialists of Atlanta - Decatur
- Mercer University - Macon
District of Columbia
- Dupont Circle Physician's Group - Washington D.C.
- Whitman-Walker Health - Washington D.C.
Arizona
- Spectrum Medical Group - Phoenix
Colorado
- Apex Research LLC - Denver
Hawaii
- Hawaii Center for AIDS, University of Hawaii - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01440569 record still lists
NCT01440569 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which DRV is the first listed.
NCT01440569 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01440569 about?
NCT01440569 is a clinical study titled "Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults". 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....
What is the current status of trial NCT01440569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2011-09. Estimated completion is 2015-10.
What conditions does trial NCT01440569 study?
This clinical trial studies the following conditions: HIV Infections, Acquired Immunodeficiency Syndrome.
What interventions are being tested in trial NCT01440569?
The interventions under investigation include: DRV (DRUG), NRTIs (DRUG), COBI (DRUG).
Who is sponsoring clinical trial NCT01440569?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01440569 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01440569's enrollment target sits among peer trials
314 113th of 542 higher than 430 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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