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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Peter J. Ruane, M.D., Inc.


Information provided by (Responsible Party)
Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier
NCT02480387

First received: June 19, 2015
Last updated: July 19, 2016
Last Verified: February 2016
History of Changes
Purpose

Purpose

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 Intervention Phase
Treatment of Hepatitis C

Drug : Ledipasvir/Sofosbuvir FDC
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Peter J. Ruane, M.D., Inc.:

Primary Outcome Measures

  • SVR12 [ Time Frame: Sustained Virologic Response 12 Weeks Post-Treatment ]

Enrollment: 20
Study Start Date: May 2015
Study Completion Date: January 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Treatment Arm
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Drug: Ledipasvir/Sofosbuvir FDC
Other Name: Harvoni
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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)

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: NCT02480387

Locations

United States, California
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036

Sponsors and Collaborators

Peter J. Ruane, M.D., Inc.
More Information

More Information


Responsible Party: Peter J. Ruane, M.D., Inc.  
ClinicalTrials.gov Identifier: NCT02480387   History of Changes  
Other Study ID Numbers: IN-US-337-1821  
Study First Received: June 19, 2015  
Last Updated: July 19, 2016  

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination

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