Hepatitis CNCT01442311
Directly Observed Hepatitis C Treatment in Methadone Clinics
A study testing enhanced DOT (both pegylated interferon alfa-2a and ribavirin) in people with Hepatitis C and Medication Adherence, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Medication Adherence
- What is being tested?
- enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV-infected
- receive HCV medical care at the methadone clinic
- plan to initiate HCV treatment on-site within the next 3 months
- psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist
- attend the methadone clinic between three and six days per week to receive methadone
- stable dose fo methadone for two weeks prior to the baseline visit
Who cannot join
- unable or unwilling to provide informed consent
- currently receiving HCV treatment
- primary HCV care provider does not agree to their participation in the trial
- psychiatrically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine Division of Substance Abuse
The Bronx, New York, 10461
About this study
Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.
- Conditions
- Hepatitis C, Medication Adherence
- Being tested
- enhanced DOT (both pegylated interferon alfa-2a and ribavirin), standard DOT (PEG-DOT control arm)
- Keywords
- Hepatitis C Virus, Chronic Hepatitis C, Methadone, Injection Drug User, Adherence, Directly Observed Treatment
- Medical subject headings
- Hepatitis C, Medication Adherence, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced DOT (both pegylated interferon alfa-2a and ribavirin)Other
Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed.
standard DOT (PEG-DOT control arm)Other
Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.
| Study group | Role | What they receive |
|---|---|---|
| enhanced DOT (PEG/RBV-DOT) | Experimental | Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed. Receives: Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin) |
| standard DOT (PEG-DOT) | Active comparator | Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home. Receives: Other: standard DOT (PEG-DOT control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence assessed by pill count, self-report, and medical records.
Measured: 24 -48 weeks
Secondary outcomes (3)
sustained viral response (SVR)
Measured: 24 weeks after treatment completion
end of treatment response (ETR)
Measured: 24 - 48 weeks
treatment completion
completion of at least 80% of planned duration of HCV treatment.
Measured: 24 - 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2007
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alain Litwin, MD, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442311
- Sponsor's protocol ID
- 2006-224
- Other IDs
- K23DA022454-01A1
- Status last verified
- Jun 2015
- First submitted
- 27 Sep 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Litwin AH, Berg KM, Li X, Hidalgo J, Arnsten JH. Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics. BMC Infect Dis. 2011 Nov 12;11:315. doi: 10.1186/1471-2334-11-315.
PubMed 22078241
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directly Observed Hepatitis C Treatment in Methadone Clinics
- ClinicalTrials.gov ID
- NCT01442311
- Acronym / sponsor ID
- 2006-224
- Conditions
- Hepatitis C, Medication Adherence
- Keywords
- Hepatitis C Virus, Chronic Hepatitis C, Methadone, Injection Drug User, Adherence, Directly Observed Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Sep 2011 (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.
Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced DOT (PEG/RBV-DOT) | Experimental | Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed. |
| standard DOT (PEG-DOT) | Active comparator | Other: standard DOT (PEG-DOT control arm)Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCV-infected
- receive HCV medical care at the methadone clinic
- plan to initiate HCV treatment on-site within the next 3 months
- psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist
- attend the methadone clinic between three and six days per week to receive methadone
Key exclusion criteria (4 listed)
- unable or unwilling to provide informed consent
- currently receiving HCV treatment
- primary HCV care provider does not agree to their participation in the trial
- psychiatrically unstable
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 |
|---|---|---|
| enhanced DOT (both pegylated interferon alfa-2a and ribavirin)Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed. | Other | enhanced DOT (PEG/RBV-DOT) |
| standard DOT (PEG-DOT control arm)Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home. | Other | standard DOT (PEG-DOT) |
Primary outcome
Adherence
Time frame: 24 -48 weeks
Adherence assessed by pill count, self-report, and medical records.
3 secondary outcomes
sustained viral response (SVR)
Time frame: 24 weeks after treatment completion
end of treatment response (ETR)
Time frame: 24 - 48 weeks
treatment completion
Time frame: 24 - 48 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 26 Jun 2015.
- Derived from this study: PubMed 22078241Litwin AH, Berg KM, Li X, Hidalgo J, Arnsten JH. Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics. BMC Infect Dis. 2011 Nov 12;11:315. doi: 10.1186/1471-2334-11-315.
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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.
Alain Litwin, MD, MPH principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced DOT (both pegylated interferon alfa-2a and ribavirin) in people with Hepatitis C and Medication Adherence, run by Albert Einstein College of Medicine 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 6 inclusion and 4 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 26 Jun 2015. 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?
Adherence (time frame: 24 -48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01442311, which also lists 1 linked publication.
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 26 Jun 2015.