Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada 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:April 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 Ritonavir-Boosted Atazanavir Plus 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 ritonavir-boosted atazanavir (ATV/r) plus the standard of
care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r +
FTC/TDF was selected as the active comparator for this study as it is a preferred protease
inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral
treatment-naive adults.


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 at screening

- 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 ATV

- 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 30 days 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, TDF, ATV, or ritonavir or
subjects with any known allergies to the excipients of Stribild tablets, Truvada
tablets, ATV capsules or ritonavir 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
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Washington, District of Columbia 20037
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4025 North Sheridan Road
Chicago, Illinois 60613
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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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...
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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...
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305 1st Avenue # Dazian 7
New York, New York 10003
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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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47 New Scotland Ave
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(518) 262-3125
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Atlanta, Georgia 30308
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Charlotte, North Carolina 28207
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Chicago, Illinois 60612
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Costa Mesa, California 92626
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Denver, California 80209
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Fort Lauderdale, Florida 33308
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Fort Lauderdale, Florida 33316
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Fort Pierce, Florida 34982
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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...
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Harlingen, Texas 78550
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Huntersville, North Carolina 28078
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Mount Vernon, New York 10550
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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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Sacramento, California 95825
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2315 Stockton Blvd.
Sacramento, California 95817
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University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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San Diego, California 92103
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Somers Point, New Jersey 08244
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Springfield, Massachusetts 01107
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