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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Peter J. Ruane, M.D., Inc. · Academic / Other
• Sex: —
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Treatment of Hepatitis C

Interventions

Type	Name	Description
DRUG	Ledipasvir/Sofosbuvir FDC

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2015-06-24
• Last updated: 2016-07-20

Locations

1 site across 1 country: United States