Armodafinil for Patients Starting Hepatitis C Virus Treatment
|ClinicalTrials.gov Identifier: NCT01470651|
Recruitment Status : Terminated (European Medicines Agency issued a drug/drug interaction: sofosbuvir/modafinil)
First Posted : November 11, 2011
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Armodafinil Drug: Sugar Pill||Phase 4|
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 (injected weekly) and ribavirin (daily pills) (IFN/RBV) for 48 weeks in order to achieve sustained virologic remission (cure). HCV treatment initiation was low, often because of concern about severe treatment side effects as well as high rates of virologic failure. Among the minority of medically eligible HCV+ patients (with or without co-morbid HIV/AIDS) who actually began treatment with IFN/RBV, side effects cause substantial attrition (about 20% by Week 12, 40% by Week 24). The most common adverse events are flu-like symptoms, of which fatigue is most prominent. Depressed mood is also common (mostly somatic symptoms).
Two new medications, telaprevir and boceprevir (protease inhibitors) have been successful in treatment of HCV in clinical trials, and both were approved by the FDA for those patients with genotype 1 HCV, and are marketed as of May 2011. One of the new drugs will be added to the current regimen for genotype 1 infection. Because both drugs are protease inhibitors, which develop rapid resistance when administered alone, they must be added to the current standard of care rather than replace it. This is expected to vastly increase willingness of doctors to recommend treatment, and for patients to agree to treatment. The investigators expect that most hepatologists will recommend, and patients agree to the addition of one of these medications from now on. However, it should be noted that both commonly cause fatigue if it isn't already present because of HCV itself, or peginterferon or ribavirin. The major adverse event associated with telaprevir is rash, and with boceprevir, anemia.
This is a 14-week placebo controlled double blind trial of armodafinil for patients about to begin HCV treatment, starting armodafinil or placebo 2 weeks prior to initiation of HCV treatment. Patients are recruited from the hepatology clinics at the respective sites. Randomization is 1:1. Placebo patients who continue HCV treatment are offered 14 weeks of armodafinil starting at Week 12 of HCV treatment when the armodafinil/placebo blind is broken.
Patients will be seen weekly for the first 4 weeks to titrate armodafinil dose and manage side effects, if any, and then biweekly, with telephone contact on the intervening weeks through Week 12. After that, monthly telephone calls through Week 24 will be conducted with patients randomized to armodafinil, and biweekly visits with placebo patients beginning armodafinil at Week 12.
The primary outcome measures concern non-adherence to INF/RBV treatment: 1) missed doses; 2) dose reductions, and 3) attrition due to side effects. Secondary outcomes include ratings of fatigue on the Fatigue Severity Scale, depression on the Patient Health Questionnaire (PHQ-9), and quality of life on the Endicott Quality of Life Enjoyment and Satisfaction Questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Armodafinil for Patients Starting Hepatitis C Treatment|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
50mg - 250mg pills, taken each morning, for 14 weeks
Other Name: Nuvigil
Placebo Comparator: Sugar pill
Inactive pill, matched to look like active medication
Drug: Sugar Pill
Inactive pill, matched to look like active medication
Other Name: Placebo Comparator
- Adherence to Medications Form [ Time Frame: HCV medication adherence reported at 12 weeks ]The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.
- Fatigue Severity Scale (FSS) [ Time Frame: Biweekly for the first month, monthly thereafter ]Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, family or social life"). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470651
|United States, New York|
|Mount Sinai Medical Center|
|New York City, New York, United States, 10029|
|New York-Presbyterian/Weill Cornell Medical Center|
|New York City, New York, United States, 10065|
|Principal Investigator:||Jeffrey Weiss, Ph.D., MS||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Stephen J. Ferrando, M.D.||Weill Medical College of Cornell University|