Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: RojanPharma Pharmaceutical Company
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

• Positive human immunodeficiency virus test

Exclusion Criteria:

• Heart rate < 50/min,

• Taking amiodarone

• Renal failure