NCT01783678

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

Conditions

• Chronic Hepatitis C
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2013-02-05
• Last updated: 2015-04-30
• Results posted: 2015-04-30

Locations

24 sites across 6 countries: Australia, France, Germany, Italy, Spain, United Kingdom