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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• HIV/AIDS

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