Armodafinil for Patients Starting Hepatitis C Virus Treatment
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 09/30/2016 |
Primero enviado: | 10/12/2011 |
Inscripción estimada enviada: | 11/09/2011 |
Publicado por primera vez: | 11/10/2011 |
Última actualización enviada: | 12/18/2016 |
Última actualización publicada: | 02/09/2017 |
Fecha de los primeros resultados enviados: | 10/24/2016 |
Fecha de los primeros resultados de CC enviados: | 12/18/2016 |
Fecha de los primeros resultados publicados: | 02/09/2017 |
Fecha de inicio real del estudio: | 09/30/2011 |
Fecha estimada de finalización primaria: | 05/31/2014 |
Fecha estimada de finalización del estudio: | 05/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Armodafinil
Drug: Sugar pill
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: Armodafinil Active medication | Drug: Armodafinil 50mg - 250mg pills, taken each morning, for 14 weeks |
Placebo Comparator: Sugar pill Inactive pill, matched to look like active medication | Drug: Sugar pill Inactive pill, matched to look like active medication |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - 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 Criteria: - 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 |
Salir
Medidas de resultado primarias
1. Adherence to Medications Form [HCV medication adherence reported at 12 weeks]
Medidas de resultado secundarias
1. Fatigue Severity Scale (FSS) [Biweekly for the first month, monthly thereafter]