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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Sofosbuvir; Drug: Daclatasvir

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Local Institution
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Local Institution
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Local Institution
    • Victoria, British Columbia, Canada, V8V 3P9
      • Local Institution
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution
    • Toronto, Ontario, Canada, M5G 2N2
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Local Institution
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Local Institution
• France
  • Marseille, France, 13009
    • Local Institution
  • Nantes, France, 44093
    • Local Institution
  • Nice Cedex, France, 06202
    • Local Institution
  • Paris, France, 75020
    • Local Institution
  • Paris, France, 75010
    • Local Institution
  • Paris, France, 75015
    • Local Institution
  • Paris Cedex 14, France, 75679
    • Local Institution
  • Paris Cedex 18, France, 75877
    • Local Institution
  • Pessac, France, 33604
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Sofosbuvir; Drug: Daclatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Proportion of subjects receiving cART who maintain HIV virologic suppression		Approximately 2 years
Proportion of subjects receiving cART who experience HIV virologic failure		Approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Slow Virus Diseases; HIV Infections; Hepatitis; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: AI444-378; 2015-003467-12 (EudraCT Number)