Clinical Trials

MainTitle

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)

This study has been completed
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02707601

First received: March 9, 2016
Last updated: October 19, 2018
Last Verified: September 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1 Infection
HCV Infection

Drug : E/C/F/TAF
Drug : F/R/TAF
Drug : LDV/SOF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12) [ Time Frame: HCV Posttreatment Week 12 ]
    Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.
Secondary Outcome Measures:
  • Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4) [ Time Frame: HCV Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment.
  • 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 [ Time Frame: 24 weeks after start of HIV treatment ]
    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.
  • 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 ]

Enrollment: 150
Study Start Date: April 1, 2016
Study Completion Date: September 29, 2017
Primary Completion Date: September 14, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Drug: E/C/F/TAF

150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily

Other Name: Genvoya®
Drug: LDV/SOF

90/400 mg FDC tablet administered orally once daily

Other Name:
  • Harvoni®
  • GS-5885/GS-7977

Experimental: 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.
Drug: F/R/TAF

200/25/25 mg FDC tablet administered orally once daily

Other Name: Odefsey®
Drug: LDV/SOF

90/400 mg FDC tablet administered orally once daily

Other Name:
  • Harvoni®
  • GS-5885/GS-7977

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02707601

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States
United States, California
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
United States, District of Columbia
The George Washington University Medical Center
Washington, District of Columbia, United States
Whitman-Walker Health
Washington, District of Columbia, United States
United States, Florida
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
Fort Pierce, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
University of Miami
Miami, Florida, United States, 33136
AIDS Healthcare Foundation
Miami, 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
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
United States, Illinois
The CORE Foundation
Chicago, Illinois, United States
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States
United States, Missouri
Kansas City Free Health Clinic
Kansas City, Missouri, United States
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States
United States, New York
Weill Cornell Medical College
New York, New York, United States
United States, North Carolina
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
United States, Pennsylvania
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
United States, Texas
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
United States, Virginia
Clinical Alliance for Research & Education
Annandale, Virginia, United States
United States, Washington
Peter Shalit MD
Seattle, Washington, United States
Southern Cal
Spokane, Washington, United States
Community Health Care
Tacoma, Washington, United States
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02707601   History of Changes  
Other Study ID Numbers: GS-US-366-1992  
  2014-004545-27  
Study First Received: March 9, 2016  
Last Updated: October 19, 2018  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

HIV
HCV
Antiretroviral therapy
HCV direct acting antiviral(s) (DAA)

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis C
Genvoya

ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.