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Trial record 31 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02457611
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : February 28, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Infection With HIV Co-Infection Drug: LDV/SOF Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: LDV/SOF
LDV/SOF FDC for 6 weeks
Drug: LDV/SOF
90/400 mg FDC tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  1. 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.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Weeks 2, 4, and 6 ]
  3. Change From Baseline in HCV RNA at Weeks 2, 4, and 6 [ Time Frame: Baseline; Weeks 2, 4, and 6 ]
  4. 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

  5. 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.

  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457611


Locations
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Germany
Berlin, Germany
Bonn, Germany
Frankfurt am Main, Germany
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02457611     History of Changes
Other Study ID Numbers: GS-US-337-1612
2014-004812-12 ( EudraCT Number )
First Posted: May 29, 2015    Key Record Dates
Results First Posted: February 28, 2017
Last Update Posted: November 16, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Slow Virus Diseases
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Infection
Communicable Diseases
Coinfection
Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Parasitic Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents