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Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968551
First Posted: October 24, 2013
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week 24.

This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.


Condition Intervention Phase
HIV-1 HIV Infections Acquired Immunodeficiency Syndrome Drug: E/C/F/TAF Drug: DRV Drug: Baseline DRV- containing ARV regimen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.


Secondary Outcome Measures:
  • Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48 [ Time Frame: Week 48 ]
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

  • Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]

Enrollment: 158
Actual Study Start Date: September 3, 2013
Study Completion Date: July 9, 2016
Primary Completion Date: July 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1

Participants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks.

Based on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks.

Drug: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
Other Name: Genvoya®
Drug: DRV
800 mg tablet administered orally once daily
Experimental: Cohort 2, Treatment Group 1
Participants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks.
Drug: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
Other Name: Genvoya®
Drug: DRV
800 mg tablet administered orally once daily
Active Comparator: Cohort 2, Treatment Group 2
Participants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks.
Drug: Baseline DRV- containing ARV regimen
Participants will take their baseline DRV- containing ARV regimen as prescribed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ability to understand and sign a written informed consent form
  • History of at least two prior antiretroviral regimens, and history of resistance to at least two different classes of antiretroviral agents
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening. Virologically suppressed on the current antiretroviral regimen containing darunavir 600 mg twice a day or 800 mg once daily continuously for ≥ 4 months preceding the screening visit and have maintained documented undetectable plasma HIV-1 RNA levels (< 50 copies/mL) and must have documentation of genotype/phenotype prior to current regimen which shows no darunavir associated resistance mutation.
  • Currently receiving raltegravir, elvitegravir, or dolutegravir (50 mg once daily, but not twice daily), or have never received integrase inhibitor, or have documentation of genotype/phenotype within 12 months prior to current regimen which must show no evidence of resistance to integrase inhibitors
  • Normal ECG
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • A female individual is eligible to enter the study if it is confirmed that she is:

    • Not pregnant or nursing
    • Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 54 years of age with cessation (for ≥ 12 months) of previously occurring menses), or
    • Of childbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose.
    • Female individuals who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
  • Male individuals must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
  • Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.

Key Exclusion Criteria:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria)
  • Hepatitis B surface antigen (HBsAg) positive
  • Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study.
  • Must not have Q151M, T69ins, or > 3 thymidine analogue mutations (TAMS) present on documented historic genotype report
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use that may interfere with individual's study compliance
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 visit
  • Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
  • Individuals receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir, cobicistat, emtricitabine, TAF, or DRV; or individuals with any known allergies to the study drugs.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968551


  Hide Study Locations
Locations
United States, Arizona
Pueblo Family Physicians, Ltd.
Phoenix, Arizona, United States, 85015
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Kaiser Permanente
Hayward, California, United States, 94545
Long Beach Education and Research Consultants
Long Beach, California, United States, 90813
Peter J Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Kaiser Permanente Medical Group
Sacramento, California, United States, 95825
Kaiser San Francisco Division of Research
San Francisco, California, United States, 94118
United States, District of Columbia
Dupont Circle Physician's Group
Washington, D.C., District of Columbia, United States, 20009
United States, Florida
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
Gary J.Richmond, MD, P.A.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
Orlando Immunology Center
Orlando, Florida, United States, 32803
Valuhealthmd/Idocf
Orlando, Florida, United States, 32806
Infectious Diseases Associates of NW FL
Pensacola, Florida, United States, 32504
Hillsborough County Health Department
Tampa, Florida, United States, 33602
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta ID Group
Atlanta, Georgia, United States, 30309
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30312
Mercer University, Mercer Medicine
Macon, Georgia, United States, 31201
United States, Illinois
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Maryland
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Harvard Medical School
Boston, Massachusetts, United States, 02215
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55404
United States, Missouri
The Kansas City Free Health Clinic/ KC Care Clinic
Kansas City, Missouri, United States, 64111
Central West Clinical Research
Saint Louis, Missouri, United States, 63108
United States, New Jersey
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany Medical College
Albany, New York, United States, 12208
New York Hospital Queens
Flushing, New York, United States, 11355
Beth Israel Medical Center
New York, New York, United States, 10003
Weill Medical College
New York, New York, United States, 10011
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center--Myer's Park
Charlotte, North Carolina, United States, 28207
Duke University Health System
Durham, North Carolina, United States, 27710
East Carolina University The Brody School of Medicine, Infectious Diseases
Greenville, North Carolina, United States, 27858
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Health System CARE Center
Akron, Ohio, United States, 44304
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
North Texas infectious Diseases Consultants, PA
Dallas, Texas, United States, 75246
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75606
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84102
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)
Annandale, Virginia, United States, 220003
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
Canada, Alberta
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R 0X7
Canada, British Columbia
Vancouver ID Research & Care Centre Society
Vancouver, British Columbia, Canada, V6Z2C7
Canada, Manitoba
Wrha - Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Maple Leaf Research
Toronto, Ontario, Canada, M5G1K2
Canada, Quebec
Clinique médicale L'actuel
Montreal, Quebec, Canada, H2l 4P9
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Publications:
Greg Huhn, Pablo Tebas, Joel Gallant et al. Strategic Simplification: the Efficacy and Safety of Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Plus Darunavir (DRV) in Treatment-Experienced HIV-1‒Infected Adults (NCT01968551). IDWeek; 2015 San Diego, CA Oct. 7-11.

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01968551     History of Changes
Other Study ID Numbers: GS-US-292-0119
First Submitted: September 26, 2013
First Posted: October 24, 2013
Results First Submitted: July 20, 2016
Results First Posted: November 1, 2016
Last Update Posted: August 14, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment-Experienced

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Tenofovir
Emtricitabine
Darunavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors