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Completed Phase 3 Interventional Results available

Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

ClinicalTrials.gov ID: NCT01440569

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.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 3:39 PM EDT

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

Study identification

NCT ID
NCT01440569
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
314 participants

Conditions and interventions

Interventions

  • COBI Drug
  • DRV Drug
  • NRTIs Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2011
Primary completion
Jul 31, 2012
Completion
Sep 30, 2015
Last update posted
Dec 13, 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 13, 2016 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01440569 live on ClinicalTrials.gov.

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