HEPATITIS CNCT02573376
Antiviral Pharmacology and Adherence in Drug Users
A study testing Directly Observed Therapy and Wirelessly Observed Therapy in people with HEPATITIS C and Virus, Human Immunodeficiency, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HEPATITIS C, Virus, Human Immunodeficiency
- What is being tested?
- Directly Observed Therapy and Wirelessly Observed Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent
- HIV-infected men and women
- Chronic HCV infection as documented by quantifiable HCV RNA
- HCV genotype 1, 4, 5, 6
- 18-70 years of age
- Willingness and ability to comply with study procedures, including DOT, WOT, and biweekly clinic visits
- Considered an active drug user by HCV provider and self-reported drug use within the past month
Who cannot join
- Glomerular filtration rate < 30 mL/min/1.73 m2
- Receipt of prior HCV treatment and radiographic, histologic, or clinical evidence of cirrhosis
- Decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy)
- Medications not recommended per the SOF/LDV prescribing information (e.g., tipranavir and other P-gp inducers, tenofovir disoproxil fumarate plus cobicistat, rosuvastatin, amiodarone)
- Any medical condition that in the opinion of the investigators will make it challenging to adhere to the study protocol, such as unstable heart disease or cancer
- Chronic Hepatitis B virus Infection
Show all 9Show fewer
- For females, active pregnancy or any intent to become pregnant
- For both sexes, an unwillingness to use contraception during the study period
- On parole or impending sentencing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.
- Conditions
- HEPATITIS C, Virus, Human Immunodeficiency
- Being tested
- Directly Observed Therapy, Wirelessly Observed Therapy
- Keywords
- HIV, Hepatitis C, Drug Abuse, Hepatitis C Virus, sofosbuvir, ledipasvir, pharmacology, pharmacokinetics
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly Observed TherapyBehavioural
Also called DOT
Wirelessly Observed TherapyBehavioural
Also called WOT
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir/Ledipasvir with Directly Observed Therapy (DOT) | Other | Participants randomized to vDOT will be provided a smart phone with cellular service and will be pre-programmed with the mobile phone-based video application and contact information for study personnel. Receives: Behavioral: Directly Observed Therapy |
| Sofosbuvir/Ledipasvir with Wirelessly Observed Therapy (WOT) | Other | Participants on WOT will be provided the Wisepill portable medication dispenser. Receives: Behavioral: Wirelessly Observed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare each individual's modeled estimate of ledipasvir and metabolites of sofosbuvir (GS-331007 and GS-331007-TP) steady state concentrations (Css) from non-linear mixed effects modeling to Css in subjects receiving DOT vs. WOT.
Measured: 12 weeks
Quantify GS-331007-TP concentrations in dried blood spots as a function of adherence (doses taken/doses prescribed).
Measured: 12 weeks
Estimate the probability of HCV cure as a function of adherence using logistic regression.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2020
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS CStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA), Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jennifer J Kiser, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573376
- Sponsor's protocol ID
- 15-0809
- Other IDs
- 1R01DA040499-01
- Status last verified
- Mar 2022
- First submitted
- 3 Jun 2015
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Pharmacology and Adherence in Drug Users
- ClinicalTrials.gov ID
- NCT02573376
- Acronym / sponsor ID
- 15-0809
- Conditions
- HEPATITIS C, Virus, Human Immunodeficiency
- Keywords
- HIV, Hepatitis C, Drug Abuse, Hepatitis C Virus, sofosbuvir, ledipasvir, pharmacology, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA), Gilead Sciences
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir/Ledipasvir with Directly Observed Therapy (DOT) | Other | Behavioral: Directly Observed TherapyParticipants randomized to vDOT will be provided a smart phone with cellular service and will be pre-programmed with the mobile phone-based video application and contact information for study personnel. |
| Sofosbuvir/Ledipasvir with Wirelessly Observed Therapy (WOT) | Other | Behavioral: Wirelessly Observed TherapyParticipants on WOT will be provided the Wisepill portable medication dispenser. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to give informed consent
- HIV-infected men and women
- Chronic HCV infection as documented by quantifiable HCV RNA
- HCV genotype 1, 4, 5, 6
- 18-70 years of age
Key exclusion criteria (9 listed)
- Glomerular filtration rate < 30 mL/min/1.73 m2
- Receipt of prior HCV treatment and radiographic, histologic, or clinical evidence of cirrhosis
- Decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy)
- Medications not recommended per the SOF/LDV prescribing information (e.g., tipranavir and other P-gp inducers, tenofovir disoproxil fumarate plus cobicistat, rosuvastatin, amiodarone)
- Any medical condition that in the opinion of the investigators will make it challenging to adhere to the study protocol, such as unstable heart disease or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directly Observed TherapyAlso: DOT | Behavioural | Sofosbuvir/Ledipasvir with Directly Observed Therapy (DOT) |
| Wirelessly Observed TherapyAlso: WOT | Behavioural | Sofosbuvir/Ledipasvir with Wirelessly Observed Therapy (WOT) |
Primary outcome
Compare each individual's modeled estimate of ledipasvir and metabolites of sofosbuvir (GS-331007 and GS-331007-TP) steady state concentrations (Css) from non-linear mixed effects modeling to Css in subjects receiving DOT vs. WOT.
Time frame: 12 weeks
Quantify GS-331007-TP concentrations in dried blood spots as a function of adherence (doses taken/doses prescribed).
Time frame: 12 weeks
Estimate the probability of HCV cure as a function of adherence using logistic regression.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer J Kiser, PharmD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly Observed Therapy and Wirelessly Observed Therapy in people with HEPATITIS C and Virus, Human Immunodeficiency, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare each individual's modeled estimate of ledipasvir and metabolites of sofosbuvir (GS-331007 and GS-331007-TP) steady state concentrations (Css) from non-linear mixed effects modeling to Css in subjects receiving DOT vs. WOT. (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.