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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
200/25/25 mg FDC tablet administered orally once daily
90/400 mg FDC tablet administered orally once daily
University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Mills Clinical Research
Los Angeles, California, United States
Peter J Ruane MD Inc
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
Sustained Virologic Response (SVR12) was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.
Time frame: HCV Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping LDV/SOF treatment.
Time frame: HCV Posttreatment Week 4
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: 24 weeks after start of HIV treatment
Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment
Time frame: Up to 32 weeks plus 30 days
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University of California San Diego
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
Community AIDS Network
Clearwater, Florida, United States
...and 33 more locations