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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02556086

Enrollment

Registered

2015-09-22

Start date

2015-12-31

Completion date

2017-07-31

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Interventions

DRUGDaclatasvir

DRUGSofosbuvir

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects with SVR12	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

Measure	Time frame	Description
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	—
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	—
Sustained virologic response (SVR12) rate	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	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	—

Countries

Canada, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026