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Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT01440569 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01440569
The ClinicalTrials.gov registry entry for NCT01440569 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01440569 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01440569?
The interventions under investigation include: DRV (DRUG), NRTIs (DRUG), COBI (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01440569?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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