3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01721265

Enrollment

145

Registered

2012-11-05

Start date

2012-10-31

Completion date

2015-03-31

Last updated

2015-04-16

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

Conditions

Hepatitis C

Keywords

HCV, Hepatitis C, IDX184, IDX719

Brief summary

All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study. In this study, researchers will try to find answers to these questions: * How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug? * Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?

Detailed description

The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained * Have participated in an Idenix-sponsored study of an Idenix DAA * Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study * Agreed to comply with the visit schedule and laboratory tests

Exclusion criteria

* Treatment with placebo only, in an Idenix sponsored study * Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA

Design outcomes

Primary

Measure	Time frame	Description
Durability of Sustained viral response [SVR]	every 3 months	To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.

Secondary

Measure	Time frame	Description
Kinetics of resistant variants	every 3 months	To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.

Outcome results