Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
NCT ID: NCT02480387
Last Updated: 2016-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2015-05-31
2016-01-31
Brief Summary
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Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
8 weeks treatment with Ledipasvir/Sofosbuvir FDC
Ledipasvir/Sofosbuvir FDC
Interventions
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Ledipasvir/Sofosbuvir FDC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening
Exclusion Criteria
* 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)
18 Years
No
Sponsors
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Peter J. Ruane, M.D., Inc.
OTHER
Responsible Party
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Locations
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Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Countries
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Other Identifiers
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IN-US-337-1821
Identifier Type: -
Identifier Source: org_study_id
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