Hepatitis CNCT02650024
Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes
An observational study of Hepatitis C and Human Immunodeficiency Virus, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Human Immunodeficiency Virus
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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).
- Other active inflammatory process (major infection, malignancy, rheumatoid arthritis/autoimmune disorder) within the prior 28 days.
- Uncontrolled or active depression or other psychiatric disorder that in the opinion of the site investigator might preclude adherence to study requirements or impact NC functioning and assessments.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hepatitis C, Human Immunodeficiency Virus
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Number of participants with abnormal laboratory values representing viral and host factors related to HCV treatment
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).
Measured: 5 years
Number of HIV-infected participants with abnormal laboratory values representing viral and host factors related to HCV treatment
Neurocognitive performance and viral and host biomarkers will be measured as mentioned above.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Bharti, University of California, San Diego
- Investigators
- Ajay Bharti, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650024
- Sponsor's protocol ID
- CO-US-337-1786
- Status last verified
- Apr 2021
- First submitted
- 24 Nov 2015
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes
- ClinicalTrials.gov ID
- NCT02650024
- Acronym / sponsor ID
- CO-US-337-1786
- Conditions
- Hepatitis C, Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- Cirrhosis or bridging fibrosis (mHAI stages 4-6 or its equivalent).
- Any cause of liver disease other than chronic HCV infection, including but not limited to the following:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment
Time frame: 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.
2 secondary outcomes
Number of participants with abnormal laboratory values representing viral and host factors related to HCV treatment
Time frame: 5 years
Number of HIV-infected participants with abnormal laboratory values representing viral and host factors related to HCV treatment
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Bharti, M.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Human Immunodeficiency Virus, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with change in neurocognitive impairment defined by Global Deficit Score (GDS) > or equal to 0.5 related to HCV treatment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.