Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
Peter J. Ruane, M.D., Inc.
Information provided by (Responsible Party)
Peter J. Ruane, M.D., Inc.
First received: June 19, 2015
Last updated: July 19, 2016
Last Verified: February 2016
History of Changes
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
Treatment of Hepatitis C
Drug : Ledipasvir/Sofosbuvir FDC
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 ]
|Study Start Date:||May 2015|
|Study Completion Date:||January 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Other Name: Harvoni
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 LocationsChoosing 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 Show More
|United States, California|
|Peter J. Ruane, MD, Inc.|
|Los Angeles, California, United States, 90036|
Sponsors and CollaboratorsPeter J. Ruane, M.D., Inc.
|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:
Ledipasvir, sofosbuvir drug combination
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.