Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:March 27, 2013
End Date:March 2019

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

A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide
(TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil
fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected
participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.


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 therapy consisting of E/C/F/TDF, EFV/FTC/TDF,
RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for ≥ 6 consecutive months preceding the final
visit in their earlier study

- Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103,
GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only
participants on an EFV-based regimen), or completion of studies GS-US-236-0104,
GS-US-216-0105

- Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive
months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening
visit

- Normal echocardiograph (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 the normal range (ULN)

- Direct bilirubin ≤ 1.5 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 sexual abstinence from screening
throughout the duration of study treatment and for 12 weeks following the last dose of
study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all
other regimens.

- Female participants 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

- Female participants 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

Key Exclusion Criteria:

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

- Hepatitis B surface antigen position

- Hepatitis C antibody positive

- Participants experiencing decompensated cirrhosis

- 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 subject study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

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

- 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 without prior approval from the sponsor is
prohibited while participating in this trial

- Participants receiving ongoing therapy with drugs not to be used with elvitegravir
(EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies
to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
92
sites
Los Angeles, California 90028
?
mi
from
Los Angeles, CA
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
4025 North Sheridan Road
Chicago, Illinois 60613
?
mi
from
Chicago, IL
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
Akron, Ohio 44304
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
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...
?
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
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
?
mi
from
Bronx, NY
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
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60657
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Costa Mesa, CA
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
Darlinghurst, New South Wales 2007
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
?
mi
from
Decatur, GA
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
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina
?
mi
from
Durham, NC
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 33308
?
mi
from
Fort Lauderdale, FL
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 33311
?
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
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenwich, Connecticut 06830
?
mi
from
Greenwich, CT
Click here to add this to my saved trials
Harlingen, Texas 78550
?
mi
from
Harlingen, TX
Click here to add this to my saved trials
Hillsborough, New Jersey 08844
?
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
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
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
Little Rock, Arkansas 72207
?
mi
from
Little Rock, AR
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 90069
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, 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
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Miami, Florida 33133
?
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
Mount Vernon, New York 10550
?
mi
from
Mount Vernon, NY
Click here to add this to my saved trials
New Haven, Connecticut 06033
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10011
?
mi
from
New York, NY
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
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
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Oakland, California 94609
?
mi
from
Oakland, CA
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
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
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
Phoenix, Arizona 85006
?
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
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...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63108
?
mi
from
Saint Louis, MO
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 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Leandro, California 94577
?
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
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
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
?
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
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
Washington, District of Columbia 20009
?
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