Hepatitis CNCT03401697
Eliminating Hepatitis C Virus
An observational study of Hepatitis C and HIV, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV, Type2 Diabetes
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2018to 1 Mar 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.
Who may be able to join
- Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
- 18 years of age or older
- HCV RNA positive
- Any HCV genotype
- Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
- Expected life expectancy sufficient to receive a benefit from HCV cure
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- No conditions that are contraindications for the use of HCV medications
- Inclusion criteria for HCV treatment in patients with type 2 diabetes
- 18 years of age or older
- HCV RNA positive
- Any HCV genotype
- Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
- Expected life expectancy sufficient to receive a benefit from HCV cure
Who cannot join
- No conditions that are contraindications for the use of HCV medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.
- Conditions
- Hepatitis C, HIV, Type2 Diabetes
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV/HCV Co-infected | Patients with HIV/HCV co-infection | |
| Type 2 Diabetes | Patients with Type 2 Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Number of Patients with sCD163 above the upper limit of normal
Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline
Measured: baseline and 3 years
Number of Type 2 Diabetes patients that initiate HCV treatment
The number of patients that initiate HCV treatment per month per patient navigator.
Measured: 3 years
Secondary outcomes (6)
sCD163
blood sample for sC163, a marker of systemic inflammation.
Measured: 3 years
Percentage of patients in need of repeated re-treatment
The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia. If such patients are identified, they will be referred for risk reduction counseling.
Measured: 3 years
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: 3 years
Number of resistance associated variant (RAV)
Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected
Measured: 3 years
FIB-4 score
The FIB-4 score of HCV positive patients with type 2 diabetes. The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests that help to estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and NASH. Formula : ( Age x AST ) / ( Platelets x ( sqr ( ALT )
Measured: 3 years
HCV cure rate
The HCV cure rate among patients with type 2 diabetes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start23 Jan 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 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 Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Branch, Icahn School of Medicine at Mount Sinai
- Investigators
- Andrea D. Branch, PhD, Principal investigator, Icahn School of Medicine at Mount Sinia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401697
- Sponsor's protocol ID
- GCO 17-1070
- Status last verified
- Mar 2021
- First submitted
- 9 Jan 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Direct outreach to providers (giving them the names of their patients who are candidates for treatment)
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV
- ClinicalTrials.gov ID
- NCT03401697
- Acronym / sponsor ID
- GCO 17-1070
- Conditions
- Hepatitis C, HIV, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV/HCV Co-infected | – | –Patients with HIV/HCV co-infection |
| Type 2 Diabetes | – | –Patients with Type 2 Diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.
Key inclusion criteria (13 listed)
- Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection
- 18 years of age or older
- HCV RNA positive
- Any HCV genotype
- Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
Key exclusion criteria (1 listed)
- No conditions that are contraindications for the use of HCV medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Number of Patients with sCD163 above the upper limit of normal
Time frame: baseline and 3 years
Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline
Number of Type 2 Diabetes patients that initiate HCV treatment
Time frame: 3 years
The number of patients that initiate HCV treatment per month per patient navigator.
6 secondary outcomes
sCD163
Time frame: 3 years
Percentage of patients in need of repeated re-treatment
Time frame: 3 years
HOMA-IR
Time frame: 3 years
Number of resistance associated variant (RAV)
Time frame: 3 years
FIB-4 score
Time frame: 3 years
HCV cure rate
Time frame: 3 years
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 24 Mar 2021.
- Individual participant dataSharing planned: Yes. Direct outreach to providers (giving them the names of their patients who are candidates for treatment)
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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.
Andrea D. Branch, PhD principal investigator
Icahn School of Medicine at Mount Sinia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and HIV, run by Icahn School of Medicine at Mount Sinai 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 13 inclusion and 1 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 24 Mar 2021. 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?
Change in the Number of Patients with sCD163 above the upper limit of normal (time frame: baseline and 3 years). The study lists 2 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 24 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.