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
NCT ID: NCT02707601
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2016-04-01
2017-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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E/C/F/TAF + LDV/SOF
Part 1: Participants will switch from 2 nucleoside reverse transcriptase inhibitors (NRTI) plus a third agent to E/C/F/TAF.
Part 2: After 8 weeks of E/C/F/TAF treatment, the participants maintaining HIV-1 RNA \< 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.
E/C/F/TAF
150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
LDV/SOF
90/400 mg FDC tablet administered orally once daily
F/R/TAF + LDV/SOF
Part 1: Participants will switch from 2 NRTI plus a third agent to F/R/TAF.
Part 2: After 8 weeks of F/R/TAF treatment, the participants maintaining HIV-1 RNA \< 50 copies/mL will start receiving LDV/SOF for 12 weeks and continue their HIV treatment until the end of the study.
F/R/TAF
200/25/25 mg FDC tablet administered orally once daily
LDV/SOF
90/400 mg FDC tablet administered orally once daily
Interventions
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E/C/F/TAF
150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
F/R/TAF
200/25/25 mg FDC tablet administered orally once daily
LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
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
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
University of Miami
Miami, Florida, United States
AIDS Healthcare Foundation
Miami, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
St. Josephs Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Rowan Tree Medical PA
Wilton Manors, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
The CORE Foundation
Chicago, Illinois, United States
Be Well Medical Center
Berkley, Michigan, United States
Kansas City Free Health Clinic
Kansas City, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Lehigh Valley Health Network, Network Office of Research and Innovation
Allentown, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Therapeutics Concepts, PA
Houston, Texas, United States
Clinical Alliance for Research & Education
Annandale, Virginia, United States
Peter Shalit MD
Seattle, Washington, United States
Southern Cal
Spokane, Washington, United States
Community Health Care
Tacoma, Washington, United States
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
Countries
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References
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Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster LB-12]. AASLD: The Liver Meeting 2017 20-24 October; Washington DC.
Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster PE16/52]. European AIDS Conference 2017 25-27 October; Milan Italy.
Huhn GD, Ramgopal M, Jain MK, Hinestrosa F, Asmuth DM, Slim J, Goldstein D, Applin S, Ryu JH, Jiang S, Cox S, Das M, Nguyen-Cleary T, Piontkowsky D, Guyer B, Rossaro L, Haubrich RH. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens. PLoS One. 2020 Jan 29;15(1):e0224875. doi: 10.1371/journal.pone.0224875. eCollection 2020.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-004545-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-366-1992
Identifier Type: -
Identifier Source: org_study_id
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