Hepatitis CNCT03551002
Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego
An observational study of Hepatitis C and Hepatitis C, Chronic, run by University of California, San Diego at 1 site in United States.
Trial summary
A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV, with history of or current HCV infection, who receive care at the UCSD Owen Clinic from 2008 to 2020
Who may be able to join
- Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
- With history of acute or chronic HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody
Who cannot join
- With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Owen Clinic-University of California, San Diego
San Diego, California, 92103-8186
Edward Cachay, MD, MAS, ecachay@ucsd.edu
About this study
Official title: Impact of Direct Acting Antivirals Uptake in Controlling Hepatitis C Epidemic and Modeling Interventions for Hepatitis C Elimination Among HIV-infected Persons in San Diego
A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.
Read the detailed description
A study that aims to quantify the state of DAA uptake and its impact on the HCV epidemic among PLWH in San Diego, and to characterize negative predictors of DAA treatment uptake among PLWH in San Diego. Retrospective and prospective data from UCSD Owen Clinic will be utilized to calculate HCV prevalence, primary incidence, and reinfection incidence. Using mathematical epidemic models, the study will assess levels of existing and scaled-up interventions necessary for HCV elimination from PLWH in San Diego.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- Keywords
- HIV, Hepatitis C, Direct acting antivirals, Hepatitis C modeling
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic, Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| Retrospective | Not described | |
| Prospective | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual proportion of HIV-infected patients who initiate direct acting antivirals
Measured: 2014-2020
Secondary outcomes (2)
Annual proportion of PLWH co-infected with HCV who are treatment naïve, previously treated with no sustained virologic response (SVR), or re-infected post-SVR
Measured: 2008-2020
Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients
Measured: 2008-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 California, San DiegoThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Cachay, MD, MAS, University of California, San Diego
- Investigators
- Edward Cachay, MD, MAS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551002
- Sponsor's protocol ID
- IN-US-334-4481
- Other IDs
- 171954
- Status last verified
- Sep 2021
- First submitted
- 23 May 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Direct Acting Antivirals Uptake in Controlling Hepatitis C Epidemic and Modeling Interventions for Hepatitis C Elimination Among HIV-infected Persons in San Diego
- ClinicalTrials.gov ID
- NCT03551002
- Acronym / sponsor ID
- IN-US-334-4481
- Conditions
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- Keywords
- HIV, Hepatitis C, Direct acting antivirals, Hepatitis C modeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jun 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.
A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.
Detailed description
A study that aims to quantify the state of DAA uptake and its impact on the HCV epidemic among PLWH in San Diego, and to characterize negative predictors of DAA treatment uptake among PLWH in San Diego. Retrospective and prospective data from UCSD Owen Clinic will be utilized to calculate HCV prevalence, primary incidence, and reinfection incidence. Using mathematical epidemic models, the study will assess levels of existing and scaled-up interventions necessary for HCV elimination from PLWH in San Diego.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | – |
| Prospective | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV, with history of or current HCV infection, who receive care at the UCSD Owen Clinic from 2008 to 2020
Key inclusion criteria (2 listed)
- Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
- With history of acute or chronic HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody
Key exclusion criteria (1 listed)
- With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020
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
Annual proportion of HIV-infected patients who initiate direct acting antivirals
Time frame: 2014-2020
2 secondary outcomes
Annual proportion of PLWH co-infected with HCV who are treatment naïve, previously treated with no sustained virologic response (SVR), or re-infected post-SVR
Time frame: 2008-2020
Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients
Time frame: 2008-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Edward Cachay, MD, MAS principal investigator
University of California, San Diego
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 Hepatitis C, Chronic, run by University of California, San Diego 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 2 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Cachay, MD, MAS ((619)543-3882, ecachay@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual proportion of HIV-infected patients who initiate direct acting antivirals (time frame: 2014-2020). 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 5 Sep 2021.