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Clinical Trials

MainTitle

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

This study has been completed
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02457611

First received: May 27, 2015
Last updated: January 6, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Condition Intervention Phase
Hepatitis C Infection With HIV Co-Infection

Drug : LDV/SOF
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 6 weeks ]
Secondary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.
  • Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Weeks 2, 4, and 6 ]
  • Change From Baseline in HCV RNA at Weeks 2, 4, and 6 [ Time Frame: Baseline; Weeks 2, 4, and 6 ]
  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]
    Virologic failure was defined as: On-treatment virologic failure confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse) Relapse HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
  • Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study. [ Time Frame: Day 1; Week 6 ]
    Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.
  • Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 [ Time Frame: Weeks 2, 4, 6, and Posttreatment Week 4 ]
  • Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4 [ Time Frame: Baseline; Week 6; Posttreatment Week 4 ]

Enrollment: 26
Study Start Date: June 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: LDV/SOF
LDV/SOF FDC for 6 weeks
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:

  • Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
  • Confirmed HIV-1 infection
  • CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
  • Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

  • Key

Exclusion Criteria:
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non HCV etiology
  • Coinfection with hepatitis B virus (HBV)
  • Treatment with any investigational drug or device within 60 days of the screening visit.
  • History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the protocol
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: NCT02457611

Locations

Germany
Berlin, Germany
Bonn, Germany
Frankfurt am Main, Germany
United Kingdom
London, United Kingdom

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02457611   History of Changes  
Other Study ID Numbers: GS-US-337-1612  
  2014-004812-12  
Study First Received: May 27, 2015  
Last Updated: January 6, 2017  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Coinfection
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.