Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:May 6, 2014
End Date:March 1, 2019

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil
fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide
(F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens
containing FTC/TDF.

This study will consist of a 96 week double-blind treatment period. After Week 96, all
participants will continue on blinded study drug treatment and attend visits every 12 weeks
until treatment assignments are unblinded. All participants will return for an unblinding
visit and will be given the option to receive open-label F/TAF and attend visits every 12
weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical
development program.


Key Inclusion Criteria:

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

- Currently receiving antiretroviral regimen containing FTC/TDF in combination with one
third agent for ≥ 6 consecutive months prior to screening.

- Plasma HIV-1 RNA levels < 50 copies/mL for at least 6 months preceding the screening
visit (measured at least twice using the same assay) and not experienced 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 electrocardiogram (ECG)

- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper
limit of the normal range (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (individuals with documented
Gilbert's syndrome or with Atazanavir-associated hyperbilirubinemia may have total
bilirubin up to 5 x ULN)

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Females of childbearing potential must agree to utilize highly effective contraception
methods or be non-heterosexually active, or practice abstinence from screening
throughout the duration of the study treatment and for 30 days following the last dose
of the study drug.

- Females who have stopped menstruating for ≥ 12 months but do not have documentation of
ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at
screening within the post-menopausal range based on the Central Laboratory reference
range.

- Females 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.

- Males 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.

Key Exclusion Criteria:

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

- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable

- Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)

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

- Females who are breastfeeding

- Positive serum pregnancy test

- 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

- Individuals receiving ongoing therapy with any of the medications not to be used with
FTC, TAF, TDF or other antiretroviral third agents.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
58
sites
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
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...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Atlanta, Georgia 30308
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Berkley, Michigan 48072
?
mi
from
Berkley, MI
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brussels,
Click here to add this to my saved trials
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75215
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80205
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80209
?
mi
from
Denver, CO
Click here to add this to my saved trials
Flushing, New York 11355
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Pierce, Florida 34982
?
mi
from
Fort Pierce, FL
Click here to add this to my saved trials
351 West Jefferson Boulevard
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Hayward, California 94545
?
mi
from
Hayward, CA
Click here to add this to my saved trials
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1125 College Avenue
Los Angeles, California 76104
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90069
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Beach, Florida 33139
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
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...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55414
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10013
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Oakland, CA
Click here to add this to my saved trials
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63139
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94118
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Fe, New Mexico 87505
?
mi
from
Santa Fe, NM
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Somers Point, New Jersey 08244
?
mi
from
Somers Point, NJ
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
3135 Florida 580
Tampa, Florida 33602
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
Washington, District of Columbia 20009
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20009
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20036
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20037
?
mi
from
Washington,
Click here to add this to my saved trials
West Palm Beach, Florida 33401
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials