Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes

NCT02650024 | Completed DMC

• 1 other identifier: CO-US-337-1786
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment

  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.

  5 years

Secondary Outcomes (2)

• Number of participants with abnormal laboratory values representing viral and host factors related to HCV treatment

  5 years

• Number of HIV-infected participants with abnormal laboratory values representing viral and host factors related to HCV treatment

  5 years

Eligibility Criteria

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

Study Population

75% of subjects will be male and 25% female. Based on the nature of the HCV clinics where the cohort will be largely recruited, we expect to enroll approximately 25-30% Hispanics, 15-20% African Americans, 2-5% Asian-Pacific Islanders, and 50% non-Hispanic whites.

You may qualify if:

• Adults (18 years old or older) with chronic HCV and NCI with a GDS greater than or equal to 0.35 (n=40).
• 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.
• Plan to receive HCV treatment from their primary care physician within 1 month of enrollment.
• 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.

You may not qualify if:

• 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.
• 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
• Alcoholic liver disease
• Drug-related liver disease
• Severe NC confounding conditions (stroke, head injury, or developmental learning disability).
• Regular use of anti-inflammatory drugs.
• Current or recent treatment with pegylated interferon (PEG-IFN).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Ucsd Hnrp

San Diego, California, 92103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens (including plasma EDTA and serum) are collected and batched for biomarker assays

MeSH Terms

Conditions

Hepatitis C; 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; 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

• Ajay Bharti, M.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: January 8, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)