Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:January 26, 2015
End Date:January 9, 2019

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

A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

The primary objective of this study is to evaluate the noninferiority of switching to
emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC)
as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in
virologically suppressed HIV-1 infected participants.


Key Inclusion Criteria:

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

- Currently receiving FTC/RPV/TDF FDC for ≥ 6 consecutive months preceding the screening
visit

- Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level
according to the local assay being used if the limit of detection is > 50 copies/mL)
for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA < 50 copies/mL,
single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed

- Have no documented resistance to any of the study agents at any time in the past

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

- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL (≤ 26 μmol/L), or normal direct bilirubin

- Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3 (1.00 GI/L);
platelets ≥ 50,000/mm^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L))

- Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible
if serum lipase is ≤ 5 × ULN)

- Normal ECG (or if abnormal, determined by the Investigator to be not clinically
significant)

- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (1.17
mL/sec) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

- Hepatitis B surface antigen (HBsAg) positive

- Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals
who have HCV antibody but no detectable HCV RNA are eligible to enroll)

- Individuals experiencing or with a medical history of decompensated cirrhosis (e.g.,
ascites, encephalopathy, etc.)

- Females who are breastfeeding

- Positive serum pregnancy test

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject 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. Individuals with cutaneous KS are
eligible, but must not have received any systemic therapy for KS within 30 days of
Baseline/Day 1 and must not be anticipated to require systemic therapy during the
study

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1

- 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
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 following medications in the
table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the
individual agents Prescribing Information); or individuals with any known allergies to
the excipients of FTC/RPV/TAF

Note: Other Inclusion/Exclusion criteria may apply.
We found this trial at
77
sites
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
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
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
?
mi
from
Longview, TX
Click here to add this to my saved trials
4600 N Habana Ave # 23
Tampa, Florida 33614
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Annandale, VA
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
Aurora, Colorado 80045
?
mi
from
Aurora, CO
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
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brussels,
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charlotte, NC
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
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Denver, Colorado
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
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
Framingham, Massachusetts 01702
?
mi
from
Framingham, MA
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 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90027
?
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
1125 College Avenue
Los Angeles, California 76104
?
mi
from
Los Angeles, CA
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
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07102
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oakland, California 94602
?
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
?
mi
from
Palm Springs, CA
Click here to add this to my saved trials
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
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
Sacramento, California
?
mi
from
Sacramento, CA
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 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Leandro, California
?
mi
from
San Leandro, 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
Savannah, Georgia 31406
?
mi
from
Savannah, GA
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
Springfield, Massachusetts 01107
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Tampa, Florida 33620
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
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 20036
?
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 20037
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia
?
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
Wilton Manors, Florida 33305
?
mi
from
Wilton Manors, FL
Click here to add this to my saved trials