Back to resultsEfficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
Primary Purpose
Treatment of Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ledipasvir/Sofosbuvir FDC
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Hepatitis C
Eligibility 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)
Sites / Locations
- Peter J. Ruane, MD, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Outcomes
Primary Outcome Measures
SVR12
Secondary Outcome Measures
Full Information
NCT ID
NCT02480387
First Posted
June 19, 2015
Last Updated
July 19, 2016
Sponsor
Peter J. Ruane, M.D., Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02480387
Brief Title
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter J. Ruane, M.D., Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Intervention Type
Drug
Intervention Name(s)
Ledipasvir/Sofosbuvir FDC
Other Intervention Name(s)
Harvoni
Primary Outcome Measure Information:
Title
SVR12
Time Frame
Sustained Virologic Response 12 Weeks Post-Treatment
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Peter J. Ruane, MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
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