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Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes | Clinical Trials | Clareo Health

COMPLETED

Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes

NCT02650024•University of California, San Diego

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•About 40 HCV+ and HCV/HIV co-infected patients with neurocognitive impairment (NCI) and a history of substance abuse will take part in this study.
•1. Adults (18 years old or older) with chronic HCV and NCI with a GDS greater than or equal to 0.35 (n=40).
•2. Presence of chronic HCV infection based on chart review will be defined as positive for anti-HCV antibody or HCV RNA at least 6 months before screening.
•3. Plan to receive HCV treatment from their primary care physician within 1 month of enrollment.
•4. For the HIV/HCV co-infected group only, subjects must have HIV. HIV status will be obtained through self-report. Self-report will be confirmed at the pretreatment visit using a HIV-1 point of care test. In the event that point of care test and self-report are discordant, then HIV status will be confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV-1 and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1 RNA viral load.

Exclusion Criteria

•1. Cirrhosis or bridging fibrosis (mHAI stages 4-6 or its equivalent).
•* Liver biopsy at any time showing mHAI stage 4 or higher fibrosis OR
•* FibroScan within 12 months demonstrating liver stiffness of ≥9.5 kPa OR
•* APRI ≥2.0 and FIB-4 ≥3.25
•* NOTE: If APRI and FIB-4 are discordant one of the other forms of fibrosis staging must be used.
•2. Any cause of liver disease other than chronic HCV infection, including but not limited to the following:
•* Hemochromatosis
•* Alpha-1 antitrypsin deficiency
•* Wilson's disease
•* Autoimmune hepatitis
+9 more criteria

Locations (1)

Ucsd Hnrp

San Diego, California, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

April 1, 2021

Completion Date

April 1, 2021

Last Updated

April 27, 2021

Enrollment

ACTUAL participants

Conditions

Hepatitis CHuman Immunodeficiency Virus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes

Inclusion Criteria

Exclusion Criteria

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