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

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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
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Newark, New Jersey 07102
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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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...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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4600 N Habana Ave # 23
Tampa, Florida 33614
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Atlanta, Georgia 30308
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Atlanta, Georgia 30309
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Aurora, Colorado 80045
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Berkley, Michigan 48072
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Beverly Hills, California 90211
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Birmingham, Alabama 35294
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Boston, Massachusetts 02115
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Boston, Massachusetts
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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...
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Detroit, Michigan 48202
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Fort Lauderdale, Florida 33316
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Fort Pierce, Florida 34982
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351 West Jefferson Boulevard
Fort Worth, Texas 76104
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Framingham, Massachusetts 01702
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Houston, Texas 77098
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Huntersville, North Carolina 28078
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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Long Beach, California 90813
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1125 College Avenue
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Miami Beach, Florida 33139
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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333 Cedar St
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1428 Madison Ave
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1428 Madison Ave
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Oakland, California 94602
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
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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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Sacramento, California 95825
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Santa Fe, New Mexico 87505
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Spokane, Washington 99204
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Springfield, Massachusetts 01199
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Springfield, Massachusetts 01107
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Tampa, Florida 33620
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Washington, District of Columbia 20036
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Wilton Manors, Florida 33305
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