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

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ClinicalTrials.gov Identifier: NCT03551002
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Edward Cachay, MD, MAS, University of California, San Diego

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.

Condition or disease
Hepatitis C Hepatitis C, Chronic HIV/AIDS

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 Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Retrospective
Prospective



Primary Outcome Measures :
  1. Annual proportion of HIV-infected patients who initiate direct acting antivirals [ Time Frame: 2014-2020 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Annual HCV chronic prevalence, primary incidence, and reinfection incidence among HIV-infected patients [ Time Frame: 2008-2020 ]

Other Outcome Measures:
  1. Estimated HCV prevalence and incidence among PLWH in San Diego using dynamic transmission modeling calibrated to epidemiological data from outcomes described above [ Time Frame: 2008-2030 ]

Biospecimen Retention:   Samples Without DNA
For patients who fail direct acting antivirals (DAA) therapy, a blood sample will be collected to conduct phylogenetic analysis


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551002


Contacts
Contact: Edward Cachay, MD, MAS (619)543-3882 ecachay@ucsd.edu

Locations
United States, California
Owen Clinic-University of California, San Diego Recruiting
San Diego, California, United States, 92103-8186
Contact: Edward Cachay, MD, MAS       ecachay@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Edward Cachay, MD, MAS University of California, San Diego

Responsible Party: Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03551002     History of Changes
Other Study ID Numbers: IN-US-334-4481
171954 ( Other Identifier: UCSD Human Research Protections Program )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edward Cachay, MD, MAS, University of California, San Diego:
HIV
Hepatitis C
Direct acting antivirals
Hepatitis C modeling

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic