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

NCT03551002 | Unknown

• 2 other identifiers: IN-US-334-4481171954
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C; Hepatitis C, Chronic; HIV/AIDS

Keywords

HIV; Hepatitis C; Direct acting antivirals; Hepatitis C modeling

Outcome Measures

Primary Outcomes (1)

• Annual proportion of HIV-infected patients who initiate direct acting antivirals

  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

  2008-2020

• Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients

  2008-2020

Other Outcomes (1)

• Estimated HCV prevalence and incidence among PLWH in San Diego using dynamic transmission modeling calibrated to epidemiological data from outcomes described above

  2008-2030

Study Arms (2)

Retrospective

Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• With no history of or current HCV infection defined as having a negative HCV antibody from 2008 to 2020

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Owen Clinic-University of California, San Diego

San Diego, California, 92103-8186, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

For patients who fail direct acting antivirals (DAA) therapy, a blood sample will be collected to conduct phylogenetic analysis

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Edward Cachay, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Cachay, MD, MAS

CONTACT

(619)543-3882; ecachay@ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 11, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)