Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2010
End Date:September 2014

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing
fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir
disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected,
antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who
are not candidates for non-nucleoside reverse transcriptor-based STRs.


Inclusion Criteria:

- Ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures

- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

- No prior use of any approved or investigational antiretroviral drug for any length of
time

- Screening genotype report must show sensitivity to FTC, TDF, and EFV

- Normal electrocardiogram (ECG)

- Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according
to the Cockcroft Gault formula)

- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase
(ALT)) ≤ 5 x the upper limit of the normal range (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Males and females of childbearing potential must agree to utilize highly effective
contraception methods from screening throughout the duration of study treatment and
for 12 weeks following the last dose of study drug

- Age ≥ 18 years

- Life expectancy ≥ 1 year

Exclusion Criteria:

- A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
the 30 days prior to screening

- Receiving drug treatment for hepatitis C, or anticipated to receive treatment for
hepatitis C

- Subjects experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects
with any known allergies to the excipients of Stribild or Atripla tablets

- Participation in any other clinical trial without prior approval

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the subject unsuitable for the study or unable to comply
with the dosing requirements
We found this trial at
98
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
801
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
676
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Birmingham, AL
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
1444
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Boston, MA
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
1289
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Brooklyn, NY
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4025 North Sheridan Road
Chicago, Illinois 60613
611
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Chicago, IL
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
400
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Longview, TX
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
1168
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Los Angeles, CA
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
1302
mi
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Manhasset, NY
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
1288
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4600 N Habana Ave # 23
Tampa, Florida 33614
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Akron, Ohio 44304
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Albany, New York 12208
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Atlanta, Georgia 30308
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Atlanta, Georgia 30309
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
1149
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Berkley, Michigan 48072
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Beverly Hills, California 90211
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Boston, Massachusetts
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
1295
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1294
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28207
959
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Chicago, Illinois 60612
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Columbia, South Carolina 29208
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346
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Dallas, Texas 75215
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805
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Denver, Colorado 80209
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Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
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Flushing, New York 11355
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Fort Lauderdale, Florida 33316
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Fort Lauderdale, Florida 33311
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Fort Lauderdale, Florida 33308
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Fort Pierce, Florida 34982
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348
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
1139
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Harlingen, Texas 78550
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Hayward, California 94545
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Hillsborough, New Jersey 08844
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Honolulu, Hawaii 96816
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Houston, Texas 77004
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Houston, Texas 77098
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Huntersville, North Carolina 28078
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Little Rock, Arkansas 72207
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Miami Beach, Florida 33139
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
636
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Minneapolis, Minnesota 55414
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Mount Vernon, New York 10550
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New Haven, Connecticut 06033
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Newport Beach, California 92663
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Oakland, California 94609
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Oakland, California 94602
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, Florida 32806
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85012
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Sacramento, California 95825
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San Diego, California 92103
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Sante Fe, New Mexico 87505
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Seattle, Washington 98104
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Somers Point, New Jersey 08244
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Spokane, Washington 99204
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Springfield, Massachusetts 01107
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Springfield, Massachusetts 01199
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St. Louis, Missouri 63108
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St. Louis, Missouri 63139
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Stamford, Connecticut 06904
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Washington, District of Columbia
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Washington, District of Columbia 20037
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Washington, District of Columbia 20009
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Winston Salem, North Carolina 27157
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