A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sofosbuvir

Criteria

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Inclusion Criteria:

• HCV RNA < 2000000 IU/mL

• Never taken medication for HCV

• No Liver Cirrhosis

• No advanced fibrosis

• Body mass index(BMI) 18-40 kg/m^2

• Genotype 1-4

Exclusion Criteria:

• Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype

• Evidence of decompensated liver

• Subjects Infected with HIV 2

• Hepatitis B virus (HBV) coinfection

• Liver Cirrhosis

• Advanced fibrosis (F3-F4)