Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:April 1, 2016
End Date:September 29, 2017

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A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens)

This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and
tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
(E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current
antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected
participants.


Key Inclusion Criteria:

- Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female
individuals, without cirrhosis, treatment-naive or treatment-experienced with
interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).

- Compensated cirrhotic individuals must be HCV treatment-naive.

- No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except
boceprevir, telaprevir and simeprevir, in combination with IFN and RBV

- Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior
to screening.

- 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 ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is
allowed.

- For individuals with 3 or more prior ARV regimens, a regimen history should be
provided for approval by the Sponsor.

- Note: Individuals that changed from TDF to TAF less than 6 months ago will be
eligible as long as the TDF/ TAF change was the only change to the regimen.

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

- Have no documented resistance to any of the HIV study agents at time in the past,
including but not limited to the reverse transcriptase resistance mutations K65R,
K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L,
the combination of K103N+L100I, or 3 or more thymidine analog associated mutations
(TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F,
K219Q/E/N/R). If a historical genotype prior to first ARV is not available or
individual had 3 or more prior ARV regimens, individual will have proviral genotype
analysis for archived resistance prior to Day 1.

- No history of HIV virologic failure

- No evidence of Hepatitis B infection

- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by
Cockcroft-Gault formula

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
43
sites
4600 N Habana Ave # 23
Tampa, Florida 33614
2523
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Tampa, FL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
2178
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Atlanta, GA
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900 East 30th Street
Austin, Texas 78705
512-480-9660
1770
mi
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Austin, TX
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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...
2072
mi
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Birmingham, AL
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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...
2329
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Chapel Hill, NC
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
2341
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Durham, NC
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
2730
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Miami, FL
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2337
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Allentown, PA
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Annandale, VA
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Atlanta, Georgia 30308
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Berkley, Michigan 48072
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Berkley, MI
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Chicago, Illinois
1733
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Chicago, IL
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Clearwater, Florida
2511
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Clearwater, FL
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
1682
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Dallas, TX
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Fort Lauderdale, Florida 33316
2718
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Fort Lauderdale, Florida 33308
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Fort Pierce, Florida 34982
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Fort Pierce, FL
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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...
2426
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Greenville, NC
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Houston, Texas 77098
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Houston, TX
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Houston, Texas
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Houston, TX
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Kansas City, Missouri 64111
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Los Angeles, California 90036
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Los Angeles, CA
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Los Angeles, California 90069
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Los Angeles, CA
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Miami, FL
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Miami Beach, Florida 33139
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New York, New York 10021
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Newark, New Jersey 07102
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Newark, NJ
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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...
2547
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Orlando, FL
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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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Philadelphia, PA
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85012
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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San Diego, California 92093
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San Francisco, California 94115
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San Francisco, CA
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San Juan,
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Savannah, Georgia 31406
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Savannah, GA
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Seattle, Washington 98104
2
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Spokane, Washington
228
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Tacoma, Washington
26
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Washington, District of Columbia
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Washington, District of Columbia 20009
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West Palm Beach, Florida 33401
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Wilton Manors, Florida 33305
2715
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