Back to results

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)

Primary Purpose

Hepatitis C

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Daclatasvir

Sofosbuvir

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daclatasvir + Sofosbuvir

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of subjects with SVR12

SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4

Secondary Outcome Measures

Sustained virologic response (SVR12) rate

SVR12 rate defined as HCV RNA < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection, by individual genotype (1-4)

Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment

Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF

Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF

Proportion of subjects receiving cART who maintain HIV virologic suppression

Proportion of subjects receiving cART who experience HIV virologic failure

Full Information

NCT ID

NCT02556086

First Posted

September 15, 2015

Last Updated

January 19, 2016

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02556086

Brief Title

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)

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daclatasvir + Sofosbuvir

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Primary Outcome Measure Information:

Title

Proportion of subjects with SVR12

Description

SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4

Time Frame

Post treatment follow-up week 12

Secondary Outcome Measure Information:

Title

Sustained virologic response (SVR12) rate

Description

Time Frame

Approximately 2 years

Title

Time Frame

Approximately 2 years

Title

Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF

Time Frame

Approximately 2 years

Title

Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF

Time Frame

Approximately 2 years

Title

Proportion of subjects receiving cART who maintain HIV virologic suppression

Time Frame

Approximately 2 years

Title

Proportion of subjects receiving cART who experience HIV virologic failure

Time Frame

Approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2C7

Country

Canada

Facility Name

Local Institution

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Local Institution

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4P 0W5

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Local Institution

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Local Institution

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Local Institution

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Local Institution

City

Paris Cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Local Institution

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Local Institution

City

Pessac

ZIP/Postal Code

33604

Country

France

12. IPD Sharing Statement

Links:

URL

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

Description

BMS clinical trial educational resource

Learn more about this trial

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)

We'll reach out to this number within 24 hrs

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)

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial