Safety and Efficacy of E/C/F/TDF (Stribild®) Versus RTV-Boosted ATV Plus FTC/TDF (Truvada®) in HIV-1 Infected, Antiretroviral Treatment-Naive Women



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/1/2018
Start Date:October 24, 2012
End Date:September 6, 2018

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A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

This study will evaluate the safety, efficacy, and tolerability of a regimen containing
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF)
fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV) plus
emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) in HIV-1 infected,
antiretroviral treatment-naive adult women.

This study will consist of two phases: Double-Blinded Treatment Phase (48 weeks) and
Open-Label Extension (OLE) Phase (48 weeks).

After 48 weeks of blinded treatment, participants will continue to take blinded study drug
for 12 weeks and return for an Unblinding Visit at Week 60. Participants who are
virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the
option to enter the OLE Phase.


Key Inclusion Criteria:

- Female (at birth), age ≥ 18 years

- Ability to understand and sign a written informed consent form

- Plasma HIV-1 RNA levels ≥ 500 copies/mL

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

- Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir
disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)

- Normal ECG

- Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to
the Cockcroft Gault formula

- Hepatic transaminases ≤ 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Women of childbearing potential must agree to utilize protocol recommended
contraception methods or be non-heterosexually active, or practice sexual abstinence
from screening throughout the duration of the study period and for 30 days following
the last dose of study drug

- Women 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.

Key Exclusion Criteria:

- A new AIDS defining condition diagnosed within the 30 days

- Females receiving drug treatment for Hepatitis C, or females who are anticipated to
receive treatment for Hepatitis C during the course of the study

- Females experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Have an implanted defibrillator or pacemaker

- Have an ECG pulse rate interval ≥ 220 msec

- Current alcohol or substance use which may potentially interfere with the female's
study compliance

- 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 requiring parenteral antibiotic or antifungal therapy
within 30 days prior to baseline

- Participation in any other clinical trial without prior approval

- Any other clinical condition or prior therapy that would make the female unsuitable
for the study or unable to comply with the dosing requirements

- Females receiving ongoing therapy with any disallowed medications, including drugs not
to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any
known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir
capsules or ritonavir tablets

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
42
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New Orleans, Louisiana 70119
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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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...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Allentown, Pennsylvania 18105
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Atlanta, Georgia 30308
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Atlanta, Georgia 30308
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Bellaire, Texas 77401
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Flushing, New York 11355
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Fort Pierce, Florida 34982
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Houston, Texas 77004
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Macon, Georgia 31201
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Newark, New Jersey 07107
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Newark, New Jersey 07102
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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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Philadelphia, Pennsylvania 19107
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Savannah, Georgia 31401
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Springfield, Massachusetts 01107
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Washington, District of Columbia 20037
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West Palm Beach, Florida 33401
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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