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
Co-STARs
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)
2 other identifiers
interventional
150
2 countries
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2016
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedResults Posted
Study results publicly available
October 9, 2018
CompletedNovember 14, 2018
September 1, 2018
1.5 years
March 9, 2016
September 12, 2018
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
HCV Posttreatment Week 12
Secondary Outcomes (3)
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
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
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
Up to 32 weeks plus 30 days
Study Arms (2)
E/C/F/TAF + LDV/SOF
EXPERIMENTALPart 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.
F/R/TAF + LDV/SOF
EXPERIMENTALPart 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (43)
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, 33136, 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
Related Publications (3)
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.
RESULTHuhn 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.
RESULTHuhn 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.
PMID: 31995556DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 14, 2016
Study Start
April 1, 2016
Primary Completion
September 14, 2017
Study Completion
September 29, 2017
Last Updated
November 14, 2018
Results First Posted
October 9, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.