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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
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)
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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
No
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
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)
Time Frame
Approximately 2 years
Title
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
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
No
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)
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