drugset / Trial / NCT02556086

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)

NCT02556086

Phase 2 Withdrawn Bristol-Myers Squibb
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-12
Primary completion
2016-06
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclatasvir Small molecule 30 mg Oral
Subject Daclatasvir Small molecule 60 mg Oral
Subject Daclatasvir Small molecule 90 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral