NCT02556086

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Geographic Reach
2 countries

17 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 20, 2016

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

September 15, 2015

Last Update Submit

January 19, 2016

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Sustained virologic response (SVR12) rate

    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

  • +1 more secondary outcomes

Study Arms (1)

Daclatasvir + Sofosbuvir

EXPERIMENTAL

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

Drug: DaclatasvirDrug: Sofosbuvir

Interventions

DaclatasvirDRUG
Daclatasvir + Sofosbuvir
SofosbuvirDRUG
Daclatasvir + Sofosbuvir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Local Institution

Edmonton, Alberta, T6G 2B7, Canada

Location

Local Institution

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Local Institution

Victoria, British Columbia, V8V 3P9, Canada

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Toronto, Ontario, M5G 2N2, Canada

Location

Local Institution

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution

Québec, Quebec, G1V 4G2, Canada

Location

Local Institution

Regina, Saskatchewan, S4P 0W5, Canada

Location

Local Institution

Marseille, 13009, France

Location

Local Institution

Nantes, 44093, France

Location

Local Institution

Nice, 06202, France

Location

Local Institution

Paris, 75010, France

Location

Local Institution

Paris, 75015, France

Location

Local Institution

Paris, 75020, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Paris, 75877, France

Location

Local Institution

Pessac, 33604, France

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirSofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 22, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

January 20, 2016

Record last verified: 2015-11

Locations

FR(9)CA(8)