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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02480387
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Peter J. Ruane, M.D., Inc.

Brief Summary:

Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA < 6 x106 IU/mL

Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment

Condition or disease Intervention/treatment Phase
Treatment of Hepatitis C Drug: Ledipasvir/Sofosbuvir FDC Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Treatment Arm
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Drug: Ledipasvir/Sofosbuvir FDC
Other Name: Harvoni

Primary Outcome Measures :
  1. SVR12 [ Time Frame: Sustained Virologic Response 12 Weeks Post-Treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
  • HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening

Exclusion Criteria:

  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
  • Solid organ transplantation.
  • Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
  • Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
  • Infection with hepatitis B virus (HBV)

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 identifier (NCT number): NCT02480387

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United States, California
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Sponsors and Collaborators
Peter J. Ruane, M.D., Inc.
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Responsible Party: Peter J. Ruane, M.D., Inc. Identifier: NCT02480387    
Other Study ID Numbers: IN-US-337-1821
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents