SIMpill Medication Dispensing Device in the Treatment of HCV
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/8/2014 |
| Start Date: | September 2012 |
| End Date: | September 2018 |
| Contact: | Andrew Aronsohn, MD |
| Email: | aaronsoh@medicine.bsd.uchicago.edu |
| Phone: | (773) 702-2300 |
Evaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C
Subjects are being asked to participate in this study because they have genotype 1 Hepatitis
C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,
and telaprevir as part of their routine care. The purpose of this study is to see if the
SIMpill automated pill dispensing device can help subjects take their medications at the
times the doctor has instructed them to take it.
The SIMpill device is an automated pill dispensing device that records a time stamp each
time the device is opened and a dose of medication is taken. Physicians can download this
data and generate a precise account of when you have taken your medication. In addition, if
a dose is missed, the SIMpill device can be set to automatically notify you by text message
if a dose is overdue. The Simpill device is a new way to keep track of when you take your
HCV medications and will also help remind you when you forget to take a dose. In addition,
this information will help your doctors understand how taking medication on time effects the
success of the therapy.
C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin,
and telaprevir as part of their routine care. The purpose of this study is to see if the
SIMpill automated pill dispensing device can help subjects take their medications at the
times the doctor has instructed them to take it.
The SIMpill device is an automated pill dispensing device that records a time stamp each
time the device is opened and a dose of medication is taken. Physicians can download this
data and generate a precise account of when you have taken your medication. In addition, if
a dose is missed, the SIMpill device can be set to automatically notify you by text message
if a dose is overdue. The Simpill device is a new way to keep track of when you take your
HCV medications and will also help remind you when you forget to take a dose. In addition,
this information will help your doctors understand how taking medication on time effects the
success of the therapy.
- Patients with genotype 1 HCV who are candidates for therapy with telaprevir, pegylated
interferon and ribavirin will be eligible for the study.
- All patients enrolled in this study will receive a standard of care regimen of
telaprevir /pegylated interferon and ribavirin. This includes medication dosages,
follow-up, and monitoring. The only exception will be the mode of medication
dispensing.
- Patients will be asked to bring their Simpill devices to their regularly scheduled
clinic visits at which time medication adherence information will be downloaded by
study personnel. Each visit will be a regularly scheduled standard of care visit and
no additional clinic visits will be needed for the patient in the Simpill study arm.
- In the event that any patient demonstrated viral breakthrough during therapy, those
patients will be offered an additional blood draw to screen for viral resistance. This
will be important to understand if patients using the Simpill device have better
adherence to the medication regiment which results in lower incidence of viral
resistance.
- Patients in the study arm will receive a text messages each time a dose of medication
is missed. This message will only go to the telephone number specified by the patient
and will not go to members of the study team. Patients who do not have text messaging
capability will not be eligible for this study.
- The initial study will be a pilot study designed to obtain preliminary data regarding
the feasibility of this device. This study is powered to detect differences in viral
kinetics over the first 4 weeks.
- In the event that Vertex receives FDA approval for BID dosage of telaprevir prior to
funding and initiation of the study, the most currently approved dosing (BID) will be
used instead of q8 hours.
interferon and ribavirin will be eligible for the study.
- All patients enrolled in this study will receive a standard of care regimen of
telaprevir /pegylated interferon and ribavirin. This includes medication dosages,
follow-up, and monitoring. The only exception will be the mode of medication
dispensing.
- Patients will be asked to bring their Simpill devices to their regularly scheduled
clinic visits at which time medication adherence information will be downloaded by
study personnel. Each visit will be a regularly scheduled standard of care visit and
no additional clinic visits will be needed for the patient in the Simpill study arm.
- In the event that any patient demonstrated viral breakthrough during therapy, those
patients will be offered an additional blood draw to screen for viral resistance. This
will be important to understand if patients using the Simpill device have better
adherence to the medication regiment which results in lower incidence of viral
resistance.
- Patients in the study arm will receive a text messages each time a dose of medication
is missed. This message will only go to the telephone number specified by the patient
and will not go to members of the study team. Patients who do not have text messaging
capability will not be eligible for this study.
- The initial study will be a pilot study designed to obtain preliminary data regarding
the feasibility of this device. This study is powered to detect differences in viral
kinetics over the first 4 weeks.
- In the event that Vertex receives FDA approval for BID dosage of telaprevir prior to
funding and initiation of the study, the most currently approved dosing (BID) will be
used instead of q8 hours.
Inclusion Criteria:
- Patients age 18 - 70 with genotype 1 HCV
- Compensated liver disease who are independently deemed an appropriate candidate for
telaprevir containing HCV treatment regimen
Exclusion Criteria:
- Prior liver transplantation
- Co-infection with other types of viral hepatitis and HIV
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