Status:
TERMINATED
Armodafinil for Patients Starting Hepatitis C Virus Treatment
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Weill Medical College of Cornell University
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Fatigue is one of the most common side effects of the treatment of hepatitis C infection with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation. Armodafinil is an F...
Detailed Description
Four million Americans have chronic hepatitis C (HCV), and 30% of HIV+ patients are co-infected with HCV. Until May 2011, the standard treatment for HCV was the combination of alpha interferon (inject...
Eligibility Criteria
Inclusion
- HCV+ patients medically cleared for IFN/RBV treatment -HIV+ or HIV-
- Speaks English
- Able and willing to give informed consent
- Fecund women: use barrier method of contraception
Exclusion
- Untreated and uncontrolled hypertension
- Left ventricular hypertrophy
- Currently taking stimulant medication
- Uncontrolled mental health problems including: MDD, suicidal or homicidal ideation, bipolar disorder, or schizophrenia
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01470651
Start Date
October 1 2011
End Date
June 1 2014
Last Update
February 10 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Medical Center
New York, New York, United States, 10029
2
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065