Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:June 29, 2015
End Date:March 2019

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A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to
emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human
immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on
regimens containing ABC/3TC.


Key Inclusion Criteria:

- The ability to understand and sign a written informed consent form

- On antiretroviral regimen containing ABC/3TC FDC in combination with one third agent
for ≥ 6 consecutive months prior to screening

- Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit
(measured at least twice using the same assay) and without experiencing two
consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two
consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year

- Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit

- Normal ECG

- Estimated glomerular filtration rate (GFR) ≥ 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

- Serum amylase ≤ 5 × ULN

- Males and females of childbearing potential must agree 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 dose of study drug

Key Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to screening

- Hepatitis B surface antigen (HBsAg) positive

- Individuals experiencing decompensated cirrhosis

- Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg,
osteoporosis)

- Pregnant or lactating females

- Have an implanted defibrillator or pacemaker

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

- A history of malignancy within the past 5 years (prior to screening) 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, in the opinion of the
investigator, 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

- Medications excluded due to the potential for interaction with emtricitabine (FTC),
TAF, ABC or 3TC

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
35
sites
Washington, District of Columbia 20009
1127
mi
from
Washington,
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900 East 30th Street
Austin, Texas 78705
512-480-9660
515
mi
from
Austin, TX
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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...
1293
mi
from
Bronx, NY
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4025 North Sheridan Road
Chicago, Illinois 60613
611
mi
from
Chicago, IL
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Atlanta, Georgia 30309
800
mi
from
Atlanta, GA
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Berkley, Michigan 48072
838
mi
from
Berkley, MI
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Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
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Dallas, Texas 75215
350
mi
from
Dallas, TX
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Fort Lauderdale, Florida 33316
1309
mi
from
Fort Lauderdale, FL
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Fort Lauderdale, Florida 33308
1307
mi
from
Fort Lauderdale, FL
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Fort Pierce, Florida 34982
1241
mi
from
Fort Pierce, FL
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348
mi
from
Fort Worth, TX
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Ghent, 9000
4690
mi
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Ghent,
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Houston, Texas 77098
570
mi
from
Houston, TX
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Houston, Texas 77004
571
mi
from
Houston, TX
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Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
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La Jolla, California 92093
1145
mi
from
La Jolla, CA
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Los Angeles, California 90069
1175
mi
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Los Angeles, CA
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Los Angeles, California 90036
1173
mi
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Los Angeles, CA
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
656
mi
from
Louisville, KY
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Minneapolis, Minnesota 55414
552
mi
from
Minneapolis, MN
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New Orleans, Louisiana 70112
697
mi
from
New Orleans, LA
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Newark, New Jersey 07102
1278
mi
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Newark, NJ
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Oakland, California 94602
1329
mi
from
Oakland, CA
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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...
1142
mi
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Orlando, FL
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Philadelphia, Pennsylvania 19107
1225
mi
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Philadelphia, PA
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Phoenix, Arizona 85012
851
mi
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Phoenix, AZ
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Saint Louis, Missouri 63139
412
mi
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Saint Louis, MO
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San Diego, California 92103
1142
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San Diego, CA
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Santa Fe, New Mexico 87505
475
mi
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Santa Fe, NM
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Seattle, Washington 98104
1410
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Seattle, WA
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Somers Point, New Jersey 08244
1256
mi
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Somers Point, NJ
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Washington, District of Columbia
1126
mi
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Washington,
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Washington, District of Columbia 20009
1127
mi
from
Washington,
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West Palm Beach, Florida 33401
1284
mi
from
West Palm Beach, FL
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