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NCT03551002 Clinical Trial

Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03551002
Other study ID # IN-US-334-4481
Secondary ID 171954
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information
Verified date September 2021
Source University of California, San Diego
Contact Edward Cachay, MD, MAS
Phone (619)543-3882
Email ecachay@ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Owen Clinic-University of California, San Diego San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Estimated HCV prevalence and incidence among PLWH in San Diego using dynamic transmission modeling calibrated to epidemiological data from outcomes described above 2008-2030
Primary Annual proportion of HIV-infected patients who initiate direct acting antivirals 2014-2020
Secondary 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 2008-2020
Secondary Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients 2008-2020
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