Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480387

Enrollment

Registered

2015-06-24

Start date

2015-05-31

Completion date

2016-01-31

Last updated

2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Hepatitis C

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

Interventions

DRUGLedipasvir/Sofosbuvir FDC

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
SVR12	Sustained Virologic Response 12 Weeks Post-Treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026