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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)

NCT ID: NCT02556086

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daclatasvir + Sofosbuvir

Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks

Group Type EXPERIMENTAL

Daclatasvir

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Interventions

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Daclatasvir

Intervention Type DRUG

Sofosbuvir

Intervention Type DRUG

Eligibility 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Edmonton, Alberta, Canada

Site Status

Local Institution

Vancouver, British Columbia, Canada

Site Status

Local Institution

Victoria, British Columbia, Canada

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Local Institution

Québec, Quebec, Canada

Site Status

Local Institution

Regina, Saskatchewan, Canada

Site Status

Local Institution

Marseille, , France

Site Status

Local Institution

Nantes, , France

Site Status

Local Institution

Nice, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Pessac, , France

Site Status

Countries

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Canada France

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2015-003467-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI444-378

Identifier Type: -

Identifier Source: org_study_id

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