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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01968551
First received: September 26, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter study is to evaluate switching from optimized antiretroviral (ARV) regimens to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus darunavir (DRV) relative to current antiretroviral regimens (ARV), and to evaluate the efficacy, safety, and tolerability of the E/C/F/TAF STR+DRV in virologically suppressed, HIV-1 positive participants.

  • Cohort 1: 20 participants will receive E/C/F/TAF STR+DRV once daily. At Week 4, safety and efficacy data from the 20 subjects in Cohort 1 will be reviewed prior to randomizing additional subjects in Cohort 2. Cohort 1 subjects will continue treatment with E/C/F/TAF plus DRV for a total of 48 weeks.
  • Cohort 2: 150 participants will be randomized in a 2:1 ratio to receive E/C/F/TAF STR+DRV once daily, or remain on their current, pre-existing, ARV regimen.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Proportion of subjects in each treatment arm in Cohort 2 with HIV-1 RNA < 50 copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects in each treatment arm in Cohort 2 with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Participants will receive E/C/F/TAF STR+DRV once daily with food for 48 weeks.
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) single-tablet regimen (STR) administered orally once daily
Drug: DRV
Darunavir (DRV) 800 mg administered orally once daily
Experimental: Cohort 2, Treatment Arm 1
Participants will be randomized to receive E/C/F/TAF STR+DRV once daily with food for 48 weeks.
Drug: E/C/F/TAF
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) single-tablet regimen (STR) administered orally once daily
Drug: DRV
Darunavir (DRV) 800 mg administered orally once daily
Active Comparator: Cohort 2, Treatment Arm 2
Participants will be randomized to continue on their current, pre-existing ARV regimen for 48 weeks.
Drug: Pre-existing ARV regimen
Participants will take their preexisting ARV regimen as prescribed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 available documentation of genotype/phenotype within 12 months prior to current regimen which must shows 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/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • A female subject 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 study drug dosing.
    • Female subjects 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 subjects 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 subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.

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
  • Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study.
  • Must not have Q151M, T69ins, or > 3 TAMS present on documented historic genotype report
  • Subjects 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 subject 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 subject 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
  • Subjects receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir, cobicistat, emtricitabine, TAF, or DRV; or subjects with any known allergies to the study drugs.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968551

Contacts
Contact: Anne Thomas Anne.Thomas@gilead.com

  Hide Study Locations
Locations
United States, Arizona
Pueblo Family Physicians, Ltd. Recruiting
Phoenix, Arizona, United States, 85015
Contact    602-264-9191      
Spectrum Medical Group Recruiting
Phoenix, Arizona, United States, 85012
Contact    602-604-9500      
United States, California
Pacific Oaks Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact    310-652-2562      
Kaiser Permanente Recruiting
Hayward, California, United States, 94545
Contact    510-784-4437      
Long Beach Education and Research Consultants Recruiting
Long Beach, California, United States, 90813
Contact    562-624-4943      
Anthony Mills MD Inc Recruiting
Los Angeles, California, United States, 90069
Contact    215-985-4448      
Peter J Ruane, MD, Inc. Recruiting
Los Angeles, California, United States, 90036
Contact    323-954-0400      
Kaiser Permanente Medical Group Recruiting
Sacramento, California, United States, 95825
Contact    916-480-6438      
Kaiser San Francisco Division of Research Recruiting
San Francisco, California, United States, 94118
Contact    415-833-3480      
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact    303-724-4929      
United States, Connecticut
Infectious Diseases Consultants of Greenwich PC Withdrawn
Greenwich, Connecticut, United States, 06830
World Health Clinicians dba circle care center Withdrawn
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Dupont Circle Physician's Group Recruiting
Washington, District of Columbia, United States, 20009
Contact    202-745-0201      
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20009
Contact    202-745-6142      
United States, Florida
Midland Florida Clinical Research Center, LLC Recruiting
DeLand, Florida, United States, 32720
Contact    407-435-9075      
Therafirst Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact    954-564-4222      
Gary J.Richmond, MD, P.A. Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact    954-524-2250      
Midway Immunology and Research Center Recruiting
Fort Pierce, Florida, United States, 34982
Contact    772-464-9746      
The Kinder Medical Group Recruiting
Miami, Florida, United States, 33133
Contact    787-497-4000      
Valuhealthmd/Idocf Recruiting
Orlando, Florida, United States, 32806
Contact    407-246-1946      
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Contact    407-647-3960      
Infectious Diseases Associates of NW FL Recruiting
Pensacola, Florida, United States, 32504
Contact    850-476-3131      
St. Joseph's Comprehensive Research Institute Recruiting
Tampa, Florida, United States, 33614
Contact    813-870-4760      
Hillsborough County Health Department Recruiting
Tampa, Florida, United States, 33602
Contact    813-307-8067      
AIDS Research and Treatment Center of the Treasure Coast Recruiting
Vero Beach, Florida, United States, 32960
Contact    772-978-9556      
Triple O Research Institute PA Recruiting
West Palm Beach, Florida, United States, 33401
Contact    561-855-7871      
Rowan Tree Medical, P.A. Recruiting
Wilton Manors, Florida, United States, 33305
Contact    954-533-5382      
United States, Georgia
Kaiser Foundation Health Plan of Georgia, Inc. Withdrawn
Atlanta, Georgia, United States, 30305
Atlanta ID Group Recruiting
Atlanta, Georgia, United States, 30309
Contact    404-351-8873      
Emory University HIV/AIDS Clinical Trials Unt Recruiting
Atlanta, Georgia, United States, 30308
Contact    404-616-3603      
AIDS Research Consortium of Atlanta Recruiting
Atlanta, Georgia, United States, 30312
Contact    404-876-2317      
Mercer University, Mercer Medicine Recruiting
Macon, Georgia, United States, 31201
Contact    478-301-5855      
United States, Illinois
Howard Brown Health Center Recruiting
Chicago, Illinois, United States, 60613
Contact    773-388-8792      
The Ruth M. Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact    312-572-4575      
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact    502-852-3905      
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact    410-706-0100      
Johns Hopkins University Recruiting
Lutherville, Maryland, United States, 21093
Contact    410-955-7473      
United States, Massachusetts
Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-927-6087      
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact    617-732-7460      
The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
Contact    413-747-5566      
Baystate Infectious Diseases Clinical Research Recruiting
Springfield, Massachusetts, United States, 01199
Contact    413-794-5887      
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact    313-916-3451      
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55404
Contact    314-910-0290      
United States, Missouri
The Kansas City Free Health Clinic/ KC Care Clinic Recruiting
Kansas City, Missouri, United States, 64111
Contact    816-777-2759      
Southampton Healthcare, Inc. Recruiting
Saint Louis, Missouri, United States, 63139
Contact    314-647-2200      
Central West Clinical Research Recruiting
St. Louis, Missouri, United States, 63108
Contact    314-652-0100      
Washington University School of Medicine: ACTU Recruiting
St. Louis, Missouri, United States, 63110
Contact    314-454-0058      
United States, Nevada
Nevada AIDS Research & Education Society Recruiting
Las Vegas, Nevada, United States, 89102
Contact    702-203-8022      
United States, New Jersey
New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact    973-972-1268      
Saint Michaels Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact    973-877-2735      
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
Contact    609-927-6662      
United States, New Mexico
Southwest CARE Center Recruiting
Santa Fe, New Mexico, United States, 87505
Contact    505-989-8200      
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact    518-262-6330      
New York Hospital Queens Recruiting
Flushing, New York, United States, 11355
Contact    718-670-1525      
Mount Sinai Withdrawn
New York, New York, United States, 10001
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact    212-420-4519      
Weill Medical College Recruiting
New York, New York, United States, 10011
Contact    212-746-7204      
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact    585-276-5903      
United States, North Carolina
Carolinas Medical Center--Myer's Park Recruiting
Charlotte, North Carolina, United States, 28207
Contact    704-355-0244      
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact    919-613-6129      
East Carolina University The Brody School of Medicine, Infectious Diseases Recruiting
Greenville, North Carolina, United States, 27858
Contact    252-744-5700      
Rosedale Infectious Diseases Recruiting
Huntersville, North Carolina, United States, 28078
Contact    704-948-8582      
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact    336-716-8918      
United States, Ohio
Summa Health System CARE Center Recruiting
Akron, Ohio, United States, 44304
Contact    330-375-4851      
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact    614-293-5856      
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-955-9725      
University Of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    214-349-8092      
Philadelphia FIGHT Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-985-4448      
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact    401-793-4089      
United States, South Carolina
University of South Carolina (USC) - Infectious Diseases Clinic Recruiting
Columbia, South Carolina, United States, 29203
Contact    803-540-1000      
United States, Texas
North Texas infectious Diseases Consultants, PA Recruiting
Dallas, Texas, United States, 75246
Contact    214-276-5618      
Trinity Health & Wellness Center Recruiting
Dallas, Texas, United States, 75208
Contact    972-807-7370      
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact    713-500-6703      
Gordon E. Crofoot MD PA Recruiting
Houston, Texas, United States, 77098
Contact    713-526-0005      
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Contact    713-526-9821      
Research Access Network Recruiting
Houston, Texas, United States, 77098
Contact    713-526-7732      
DCOL Center for Clinical Research Recruiting
Longview, Texas, United States, 75606
Contact    903-238-8854      
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84102
Contact    801-585-9814      
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID) Recruiting
Annandale, Virginia, United States, 220003
Contact    703-560-4821      
United States, Washington
Peter Shalit, MD Recruiting
Seattle, Washington, United States, 98104
Contact    206-624-1441      
Canada, Alberta
Southern Alberta Clinic Recruiting
Calgary, Alberta, Canada, T2R 0X7
Contact    403-955-6309      
Canada, British Columbia
Vancouver ID Research & Care Centre Society Recruiting
Vancouver, British Columbia, Canada, V6Z2C7
Contact    604-642-6429      
Canada, Manitoba
Wrha - Health Sciences Centre Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact    204-787-3244      
Canada, Ontario
Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact    613-737-8208      
Maple Leaf Research Recruiting
Toronto, Ontario, Canada, M5G1K2
Contact    416-465-7936      
Canada, Quebec
Clinique OPUS Inc. Recruiting
Montreal, Quebec, Canada, H3A1T1
Contact    514-787-6787      
Reseach Institute of the MUHC Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact    514-934-1934      
Clinique médicale L'actuel Recruiting
Montreal, Quebec, Canada, H2l 4P9
Contact    514-524-3642      
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Moupali Das, MD, MPH Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01968551     History of Changes
Other Study ID Numbers: GS-US-292-0119
Study First Received: September 26, 2013
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Tenofovir
Darunavir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014