Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:May 30, 2018
End Date:August 2023
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

The primary objective of this study is to evaluate the efficacy of fixed-dose combination
(FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG)
+ emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV)
treatment naive, HIV-1 and HBV co-infected adults.


Key Inclusion Criteria:

- HIV-1 co-infection:

- Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL
at screening

- ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine
and entecavir, following a diagnosis of HIV-1 infection (except the use for
pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one
month prior to screening)

- Screening genotype report must show sensitivity to emtricitabine (FTC) and
tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively,
if genotype results from a local laboratory obtained ≤ 90 days prior to screening
visit date show sensitivity to these drugs, this genotype will be acceptable to
fulfill this inclusion criterion in the event that the genotype obtained at
screening is not yet available and all other inclusion/exclusion criteria have
been confirmed

- HBV co-infection:

- Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)

- Screening HBV DNA ≥ 2000 IU/mL

- Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of
normal (ULN)

- Total bilirubin ≤ 2.5 x ULN

Key Exclusion Criteria:

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

- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment

- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance

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

- Participation in any other clinical trial, including observational studies, without
prior approval from the sponsor is prohibited while participating in this trial

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
24
sites
Atlanta, Georgia 30308
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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4025 North Sheridan Road
Chicago, Illinois 60613
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Chicago, IL
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4600 N Habana Ave # 23
Tampa, Florida 33614
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1964 West Eleven Mile Road
Berkeley, California 48072
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Berkeley, CA
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Cincinnati, OH
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Dallas, TX
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Detroit, Michigan 48202
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Fort Pierce, Florida 34982
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Houston, TX
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Huntersville, North Carolina 28078
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Macon, GA
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Miami, Florida 33133
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Miami Beach, Florida 33139
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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...
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New Haven, CT
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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...
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Phoenix, Arizona 85012
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Sacramento, CA
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Saint Louis, Missouri 63139
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4202 East Fowler Avenue
Tampa, Florida 33613
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Washington, District of Columbia 20009
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Washington, District of Columbia 20052
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West Palm Beach, Florida 33401
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