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



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:September 3, 2013
End Date:July 9, 2016

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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

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.


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.
We found this trial at
57
sites
Atlanta, Georgia 30308
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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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4025 North Sheridan Road
Chicago, Illinois 60613
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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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...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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4600 N Habana Ave # 23
Tampa, Florida 33614
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Annandale, VA
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Atlanta, Georgia 30309
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Beverly Hills, California 90211
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Boston, Massachusetts 02115
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Calgary, Alberta
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Charlotte, North Carolina 28207
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Chicago, Illinois 60612
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Detroit, Michigan 48202
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Durham, North Carolina
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Flushing, New York 11355
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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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Hayward, California 94545
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Houston, Texas 77098
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Houston, Texas 77004
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Long Beach, California 90813
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Los Angeles, California 90036
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1101 East 33rd Street
Lutherville, Maryland 21093
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Macon, Georgia 31201
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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New York, New York 10065
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Orlando, Florida 32806
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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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Pensacola, Florida 32504
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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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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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Phoenix, Arizona 85015
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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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Sacramento, California 95825
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Saint Louis, Missouri 63108
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San Francisco, California 94118
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Santa Fe, New Mexico 87505
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Seattle, Washington 98104
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Somers Point, New Jersey 08244
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Springfield, Massachusetts 01199
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Washington, District of Columbia 20009
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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
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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