NCT01667731

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 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 GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Conditions

• Hepatitis C
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	SOF	Sofosbuvir (SOF) 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: 2012-07-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2012-08-17
• Last updated: 2014-11-21
• Results posted: 2014-11-21

Locations

27 sites across 2 countries: United States, Puerto Rico