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History of Changes for Study: NCT02073656
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Latest version (submitted October 19, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 25, 2014 None (earliest Version on record)
2 February 28, 2014 Recruitment Status, Study Status and Contacts/Locations
3 April 2, 2014 Study Status and Contacts/Locations
4 May 1, 2014 Study Status and Contacts/Locations
5 June 11, 2014 Recruitment Status, Study Status and Contacts/Locations
6 December 18, 2014 Outcome Measures, Study Status and Arms and Interventions
7 July 1, 2015 Study Status and Study Design
8 September 23, 2015 Study Status
9 December 8, 2015 Recruitment Status and Study Status
10 August 30, 2016 Outcome Measures, Study Status, Arms and Interventions, References, Results, Eligibility and Study Description
11 October 19, 2018 Study Status and IPDSharing
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Study NCT02073656
Submitted Date:  February 25, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: GS-US-337-0115
Brief Title: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
Official Title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Not yet recruiting
Study Start: February 2014
Primary Completion: March 2015 [Anticipated]
Study Completion: June 2016 [Anticipated]
First Submitted: February 25, 2014
First Submitted that
Met QC Criteria:
February 25, 2014
First Posted: February 27, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 25, 2014
Last Update Posted: February 27, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy.

Detailed Description:
Open or close this module Conditions
Conditions: Hepatitis C Virus
HIV
Keywords: genotype 1
genotype 4
HIV
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LDV/SOF 12 weeks
Participants will receive LDV/SOF for 12 weeks.
Drug: LDV/SOF
LDV 90 mg/ SOF 400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885
Experimental: Retreatment substudy
Participants in the retreatment substudy will receive LDV/SOF plus RBV for 24 weeks.
Drug: LDV/SOF
LDV 90 mg/ SOF 400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
[ Time Frame: Posttreatment Week 12 ]

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
2. Incidence of adverse events leading to permanent discontinuation of study drug(s)
[ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures:
1. Proportion of participants with sustained virologic response at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
[ Time Frame: Posttreatment Weeks 4 and 24 ]

SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
2. Proportion of participants with HCV RNA < LLOQ on treatment
[ Time Frame: Up to 12 weeks ]

3. Change in HCV RNA from Baseline
[ Time Frame: Baseline to posttreatment Week 24 ]

4. Proportion of participants with virologic failure
[ Time Frame: Baseline to posttreatment Week 24 ]

Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), nonresponse (HCV RNA ≥ LLOQ through 12 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 12, or 24 weeks posttreatment).
5. For retreatment group only: Proportion of participants with sustained virologic response at 4, 12 and 24 weeks after discontinuation of therapy (SVR4, SVR12, and SVR24)
[ Time Frame: Posttreatment Weeks 4, 12, and 24 ]

6. Proportion of participants that maintain HIV-1 RNA < 50 copies/mL while on treatment
[ Time Frame: Baseline to Week 12 ]

7. Change from baseline of serum creatinine at end of treatment, posttreatment weeks 12 and 24
[ Time Frame: Week 12 and posttreatment weeks 12 and 24 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • HCV RNA ≥ 10,000 IU/mL at screening
  • HCV genotype 1 or 4
  • HIV-1 infection
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Current or prior history of Clinical hepatic decompensation Hepatocellular carcinoma (HCC) or other Malignancy (with the exception of certain resolved skin cancers)
  • Hepatitis B virus (HBV) infection
  • Pregnant or nursing female
  • Chronic use of systemically administered immunosuppressive agents
Open or close this module Contacts/Locations
Central Contact Person: Clinical Study Team
Email: 337-0115@gilead.com
Study Officials: Jenny Yang, PharmD
Study Director
Gilead Sciences
Locations: United States, Alabama
Birmingham, Alabama, United States, 35294-2170
United States, California
Los Angeles, California, United States, 90027
Newport Beach, California, United States, 92663
Palo Alto, California, United States, 94304-5350
Sacramento, California, United States, 95817
San Diego, California, United States, 92103
San Francisco, California, United States, 94110
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80209
United States, District of Columbia
Washington, District of Columbia, United States, 20815
United States, Florida
Bradenton, Florida, United States, 34209
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Bronx, New York, United States, 10468
New York, New York, United States, 10065
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267-0595
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77004
United States, Virginia
Annandale, Virginia, United States, 22003
Richmond, Virginia, United States, 23298-0341
United States, Washington
Seattle, Washington, United States, 98104
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal, Quebec, Canada, H2L 5B1
New Zealand
Auckland, New Zealand, 1142
Christchurch, New Zealand, 8011
Puerto Rico
San Juan, Puerto Rico, 00936-5607
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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