Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes

Completed

• Conditions: Hepatitis C; Human Immunodeficiency Virus

• Registration Number: NCT02650024
• Lead Sponsor: University of California, San Diego

Brief Summary

This study observes the effects of newly developed direct-acting antiviral (DAA) treatments on the central nervous system (CNS) of individuals with chronic Hepatitis C (HCV). The goals of this study are to determine the CNS impact of curing chronic HCV disease with newly established DAA therapies and how HIV alters this relationship.

Detailed Description

The specific aims of the study are as follows:

Aim 1. Impact of HCV Cure on CNS Outcomes. Determine how curing HCV without IFN alters CNS outcomes in substance users with chronic HCV disease.

Aim 2. Correlates of CNS Outcomes. Determine the viral and host correlates of Aim 1's neurocognitive outcomes.

Aim 3. Impact of HIV Co-infection. Explore how HIV alters the relationships observed in Aims 1 and 2. Hypothesis 3: Compared with HCV mono-infected adults, SVR will be less likely to result in improved CNS outcomes in HCV/HIV co-infected adults.

Study Timeline

• Study First Submitted: 2015-11-24
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Status Verified: 2021-04
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Last Update Submitted: 2021-04-24
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment	5 years	Neurocognitive impairment, defined as GDS \> or equal to 0.35, will be tested using a battery of tests covering 7 neurocognitive ability domains that include verbal fluency, information processing speed, learning, memory, executive functions, attention and working memory, fine motor skills.

Secondary Outcome Measures

Name	Time	Method
Number of participants with abnormal laboratory values representing viral and host factors related to HCV treatment	5 years	Viral factors: i) HCV RNA: will be measured according to the manufacturer's instructions (limit of detection 30 IU/mL). Enzyme-linked immunosorbent assay (ELISA) kits or multiplex assays will be used for measuring soluble biomarkers in cerebrospinal fluid (CSF) and plasma. ii) HCV core protein: Quantitative ELISA (limit of detection 1 ng/mL). Host factors: i) Neurofilament-light: Quantitative ELISA (limit of detection 50 pg/mL). ii) Soluble tumor necrosis factor receptor-II (sTNFR-II): Quantitative ELISA (limit of detection 2.3 pg/mL). iii) Macrophage Inflammatory protein--1β (MIP-1β), Interleukin-18 (IL-18) and Interferon gamma-induced protein-10 (IP-10). iv) sCD14: (sensitivity 125 pg/mL). v) sCD163: (limit of detection 0.613 ng/mL). vi) Neopterin: Quantitative ELISA (limit of detection 0.7 nmol/L).
Number of HIV-infected participants with abnormal laboratory values representing viral and host factors related to HCV treatment	5 years	Neurocognitive performance and viral and host biomarkers will be measured as mentioned above.

Trial Locations

Locations (1)

Ucsd Hnrp; 🇺🇸 San Diego, California, United States