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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)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02556086
First Posted: September 22, 2015
Last Update Posted: January 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Hepatitis C Drug: Daclatasvir Drug: Sofosbuvir Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects with SVR12 [ Time Frame: Post treatment follow-up week 12 ]
    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 [ Time Frame: Approximately 2 years ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 2 years ]
  • Proportion of subjects receiving cART who maintain HIV virologic suppression [ Time Frame: Approximately 2 years ]
  • Proportion of subjects receiving cART who experience HIV virologic failure [ Time Frame: Approximately 2 years ]

Enrollment: 0
Study Start Date: December 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Daclatasvir Drug: Sofosbuvir

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556086


Locations
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2C7
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H4A 3J1
Canada, Saskatchewan
Local Institution
Regina, Saskatchewan, Canada, S4P 0W5
Canada
Local Institution
Quebec, Canada, G1V 4G2
France
Local Institution
Marseille, France, 13009
Local Institution
Nantes, France, 44093
Local Institution
Nice Cedex, France, 06202
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Paris Cedex 18, France, 75877
Local Institution
Paris, France, 75010
Local Institution
Paris, France, 75015
Local Institution
Paris, France, 75020
Local Institution
Pessac, France, 33604
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02556086     History of Changes
Other Study ID Numbers: AI444-378
2015-003467-12 ( EudraCT Number )
First Submitted: September 15, 2015
First Posted: September 22, 2015
Last Update Posted: January 20, 2016
Last Verified: November 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents