- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480387
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
July 19, 2016 updated by: Peter J. Ruane, M.D., Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90036
- Peter J. Ruane, MD, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment Arm
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SVR12
Time Frame: Sustained Virologic Response 12 Weeks Post-Treatment
|
Sustained Virologic Response 12 Weeks Post-Treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
June 19, 2015
First Submitted That Met QC Criteria
June 19, 2015
First Posted (ESTIMATE)
June 24, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
July 20, 2016
Last Update Submitted That Met QC Criteria
July 19, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- IN-US-337-1821
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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