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)

October 19, 2018 updated by: Gilead Sciences

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
        • Clinical Research Puerto Rico Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States
        • Spectrum Medical Group
    • California
      • Los Angeles, California, United States
        • Peter J Ruane Md Inc
      • Los Angeles, California, United States
        • Mills Clinical Research
      • Sacramento, California, United States
        • University of California Davis
      • San Diego, California, United States
        • University of California San Diego
      • San Francisco, California, United States
        • Kaiser Permanente
    • District of Columbia
      • Washington, District of Columbia, United States
        • Whitman-Walker Health
      • Washington, District of Columbia, United States
        • The George Washington University Medical Center
    • Florida
      • Clearwater, Florida, United States
        • Community AIDS Network
      • Fort Lauderdale, Florida, United States
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale, Florida, United States
        • Therafirst Medical Center
      • Fort Pierce, Florida, United States
        • Midway Immunology & Research Center, LLC
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States
        • AIDS Healthcare Foundation
      • Miami Beach, Florida, United States
        • AIDS Healthcare Foundation
      • Orlando, Florida, United States
        • Orlando Immunology Center
      • Tampa, Florida, United States
        • St. Josephs Comprehensive Research Institute
      • West Palm Beach, Florida, United States
        • Triple O Research Institute PA
      • Wilton Manors, Florida, United States
        • Rowan Tree Medical PA
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
      • Atlanta, Georgia, United States
        • AIDS Research Consortium of Atlanta
      • Savannah, Georgia, United States
        • Chatham County Health Department
    • Illinois
      • Chicago, Illinois, United States
        • The CORE Foundation
    • Michigan
      • Berkley, Michigan, United States
        • Be Well Medical Center
    • Missouri
      • Kansas City, Missouri, United States
        • Kansas City Free Health Clinic
    • New Jersey
      • Newark, New Jersey, United States
        • Saint Michael's Medical Center
    • New York
      • New York, New York, United States
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States
        • Duke University
      • Greenville, North Carolina, United States
        • East Carolina University
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Lehigh Valley Health Network, Network Office of Research and Innovation
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Philadelphia FIGHT
    • Texas
      • Austin, Texas, United States
        • Central Texas Clinical Research
      • Dallas, Texas, United States
        • UT Southwestern Medical Center
      • Houston, Texas, United States
        • Gordon E. Crofoot MD PA
      • Houston, Texas, United States
        • Therapeutics Concepts, PA
    • Virginia
      • Annandale, Virginia, United States
        • Clinical Alliance for Research & Education
    • Washington
      • Seattle, Washington, United States
        • Peter Shalit MD
      • Spokane, Washington, United States
        • Southern Cal
      • Tacoma, Washington, United States
        • Community Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: E/C/F/TAF
150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
  • Genvoya®
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: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Drug: F/R/TAF
200/25/25 mg FDC tablet administered orally once daily
Other Names:
  • Odefsey®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
HCV Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
Up to 32 weeks plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

September 14, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-366-1992
  • 2014-004545-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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