3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
|ClinicalTrials.gov Identifier: NCT01721265|
Recruitment Status : Terminated
First Posted : November 5, 2012
Last Update Posted : April 16, 2015
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?
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- Durability of Sustained viral response [SVR] [ Time Frame: every 3 months ]To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
- Kinetics of resistant variants [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA