Clinical trial NCT02556086: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Proportion of subjects with SVR12
timeFrame: Post treatment follow-up week 12
Secondary outcomes:
measure: Sustained virologic response (SVR12) rate
timeFrame: Approximately 2 years
measure: 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
timeFrame: Approximately 2 years
measure: 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
timeFrame: Approximately 2 years
measure: 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
timeFrame: Approximately 2 years
measure: Proportion of subjects receiving cART who maintain HIV virologic suppression
timeFrame: Approximately 2 years
measure: Proportion of subjects receiving cART who experience HIV virologic failure
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Regina
country: Canada
facility: Local Institution
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Nice Cedex
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Paris Cedex 18
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: