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 Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02556086
• Other study ID #: AI444-378
• Secondary ID: 2015-003467-12
• Status: Withdrawn
• Phase: Phase 2
• First received: September 15, 2015
• Last updated: January 19, 2016
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Daclatasvir

• Sofosbuvir

Locations

Country	Name	City	State
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Quebec
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
France	Local Institution	Marseille
France	Local Institution	Nantes
France	Local Institution	Nice Cedex
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris Cedex 14
France	Local Institution	Paris Cedex 18
France	Local Institution	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post treatment follow-up week 12	No
Secondary	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)	Approximately 2 years	No
Secondary	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		Approximately 2 years	Yes
Secondary	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		Approximately 2 years	No
Secondary	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		Approximately 2 years	No
Secondary	Proportion of subjects receiving cART who maintain HIV virologic suppression		Approximately 2 years	No
Secondary	Proportion of subjects receiving cART who experience HIV virologic failure		Approximately 2 years	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form