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.

Status and phase

Completed

Phase 2

Conditions

Treatment of Hepatitis C

Treatments

Drug: Ledipasvir/Sofosbuvir FDC

Study type

Interventional

Funder types

Other

Identifiers

NCT02480387

IN-US-337-1821

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)