HIVNCT00747539
Brain Deficits in HIV/HCV Coinfected People Before and After Anti-HCV Therapy
An observational study of HIV and Hepatitis C, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits in people who are infected with both HIV and the hepatitis C virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C, Infections
- What is being tested?
- Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)
- How many people
- 330 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2008to Jun 2015
- 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: The study population will include 165 HCV-monoinfected and 165 HIV/HCV-coinfected participants who are receiving HIV and/or HCV treatment through the VA Greater Los Angeles Health Care System, the AIDS Healthcare Foundation, or the Kaiser-Permanente Infectious Disease Program.
Who may be able to join
- Diagnosis of HCV with detectable HCV RNA in serum
- Meets clinical criteria for initiating HCV therapy
- Lives in the community and not in a board and care, nursing home, hospice, or other residential setting in which a professional caregiver would dispense necessary medication. Living with a partner, roommate, or other family members who may assist with caregiving, including reminding participants to take medication, is acceptable.
- Responsible for administering own medications
- Diagnosis of HIV-associated neurocognitive disorder (HAND) will not be cause for exclusion, so long as participant is able to demonstrate the ability to grant full informed consent
- HIV or HCV disease severity will not be cause for exclusion (e.g., CDC Groups A, B, and C are all eligible); although, if severely ill because of either HIV (e.g., uncontrolled viremia, severely immunosuppressed) or HCV (e.g., cryoglobulinemia, hepatic encephalopathy) will not be eligible for PEG-IFN/RBV therapy
- Able to read English at the 6th grade level
Who cannot join
- Current or past psychotic spectrum disorder, including schizophrenia, schizophreniform disorder, or bipolar disorder
- History of learning disability, seizure disorder, closed-head injury with loss of consciousness in excess of 30 minutes, or any other neurological disease
- Evidence of any central nervous system opportunistic infection or neoplasm
- Diagnosed with Hepatitis B
- Previous failed course of HCV therapy
- Those judged to be significantly depressed by the study psychiatrists/psychologists (defined as current major depressive disorder of moderate or severe severity) or with evidence of suicidal ideation will not be enrolled until clinical condition is stabilized.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente Infectious Diseases, Antelope Valley
Lancaster, California, 93534
University of California, Los Angeles, School of Medicine
Los Angeles, California, 90024
AIDS Healthcare Foundation
Los Angeles, California, 90028
Veterans Administration Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
Official title: Neurobehavioral Deficits in HIV/HCV Infection Pre/Post Anti-HCV Therapy
This study will evaluate the impact of standard hepatitis C virus treatment on brain deficits in people who are infected with both HIV and the hepatitis C virus.
Read the detailed description
The World Health Organization estimates at least 3% of the world's population is infected with chronic hepatitis C virus (HCV), and up to one third of all HIV infected people are coinfected with HCV. HCV can damage the liver cells and cause liver diseases such as cirrhosis and hepatocellular carcinoma. People infected with HCV can also suffer from neurocognitive deficits, including problems with information processing, slowing of muscular processes related to thinking, and difficulty focusing on complex things. These neurocognitive deficits are similar to those found in HIV infected individuals, and previous research indicates that people infected with both HIV and HCV have greater overall cognitive impairments. This study aims to determine the impact of anti-HCV treatment on neurocognitive, neuropsychiatric, and neuroimaging factors in people infected with HCV and people coinfected with both HCV and HIV. The study also aims to measure whether possible neurocognitive improvements from anti-HCV treatment are related to a physical health outcome, measured as a sustained virologic response, and whether adherence to the medication schedule laid out for the participants influences possible positive effects on either neurocognitive or physical health.
Two kinds of participants will be recruited for this study: those infected with HCV and those infected with both HCV and HIV. These two groups will be compared to determine how comorbid HCV and HIV infection affects treatment outcomes. The treatment specified for HCV is pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV. Participants will continue to see their doctors as regularly scheduled, and any other prescribed medications or advice concerning HCV treatment will be noted by researchers. All participants will be tested at baseline, after 12 weeks of treatment, and 12 weeks after the completion of treatment. A subset from each group of participants will undergo additional neuroimaging tests. Participation in this study will last for varied amounts of time depending on the recommended treatments for HCV. Based on each virus' genotype and rapid virologic response, the treatment period for HCV may last 24 or 48 weeks, with further extensions of 12 to 24 weeks in some cases.
During the three testing sessions, each lasting 5 hours, participants' health, cognitive functioning, and medication adherence will be measured. Testing will include self-report measures, intelligence tests, tasks designed to assess cognitive functioning, and motor functioning tasks. Urine tests screening for narcotics will also be collected. In addition to self-report measures, caps to pill bottles storing HCV medication will automatically record every time the cap is removed to measure adherence to the medication schedule.
- Conditions
- HIV, Hepatitis C, Infections
- Being tested
- Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)
- Keywords
- Hepatitis C Virus, HCV, Human Immunodeficiency Virus, Coinfection
- Medical subject headings
- Hepatitis C, Infections, Acquired Immunodeficiency Syndrome, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)Drug
Also called Pegasys
Pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV, will be given to participants.
| Study group | Role | What they receive |
|---|---|---|
| 1 | This group will be composed of 165 HCV-infected people who are not also HIV infected. Receives: Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV) | |
| 2 | This group will be composed of 165 HCV-infected people who are also HIV infected. Receives: Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral deficits as observed on neuropsychological testing in HIV/HCV-coinfected individuals before and after receiving anti-HCV treatment.
Measured: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
Secondary outcomes (2)
Psychiatric symptoms
Measured: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
Neuroimaging data (from a nested cohort of participants)
Measured: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Charles Hinkin, University of California, Los Angeles
- Investigators
- Charles H. Hinkin, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747539
- Sponsor's protocol ID
- R01MH083553
- Other IDs
- R01MH083553, DAHBR 9A-ASNM
- Status last verified
- May 2016
- First submitted
- 4 Sep 2008
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Deficits in HIV/HCV Infection Pre/Post Anti-HCV Therapy
- ClinicalTrials.gov ID
- NCT00747539
- Acronym / sponsor ID
- R01MH083553
- Conditions
- HIV, Hepatitis C, Infections
- Keywords
- Hepatitis C Virus, HCV, Human Immunodeficiency Virus, Coinfection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Sep 2008 (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 will evaluate the impact of standard hepatitis C virus treatment on brain deficits in people who are infected with both HIV and the hepatitis C virus.
Detailed description
The World Health Organization estimates at least 3% of the world's population is infected with chronic hepatitis C virus (HCV), and up to one third of all HIV infected people are coinfected with HCV. HCV can damage the liver cells and cause liver diseases such as cirrhosis and hepatocellular carcinoma. People infected with HCV can also suffer from neurocognitive deficits, including problems with information processing, slowing of muscular processes related to thinking, and difficulty focusing on complex things. These neurocognitive deficits are similar to those found in HIV infected individuals, and previous research indicates that people infected with both HIV and HCV have greater overall cognitive impairments. This study aims to determine the impact of anti-HCV treatment on neurocognitive, neuropsychiatric, and neuroimaging factors in people infected with HCV and people coinfected with both HCV and HIV. The study also aims to measure whether possible neurocognitive improvements from anti-HCV treatment are related to a physical health outcome, measured as a sustained virologic response, and whether adherence to the medication schedule laid out for the participants influences possible positive effects on either neurocognitive or physical health.
Two kinds of participants will be recruited for this study: those infected with HCV and those infected with both HCV and HIV. These two groups will be compared to determine how comorbid HCV and HIV infection affects treatment outcomes. The treatment specified for HCV is pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV. Participants will continue to see their doctors as regularly scheduled, and any other prescribed medications or advice concerning HCV treatment will be noted by researchers. All participants will be tested at baseline, after 12 weeks of treatment, and 12 weeks after the completion of treatment. A subset from each group of participants will undergo additional neuroimaging tests. Participation in this study will last for varied amounts of time depending on the recommended treatments for HCV. Based on each virus' genotype and rapid virologic response, the treatment period for HCV may last 24 or 48 weeks, with further extensions of 12 to 24 weeks in some cases.
During the three testing sessions, each lasting 5 hours, participants' health, cognitive functioning, and medication adherence will be measured. Testing will include self-report measures, intelligence tests, tasks designed to assess cognitive functioning, and motor functioning tasks. Urine tests screening for narcotics will also be collected. In addition to self-report measures, caps to pill bottles storing HCV medication will automatically record every time the cap is removed to measure adherence to the medication schedule.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)This group will be composed of 165 HCV-infected people who are not also HIV infected. |
| 2 | – | Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)This group will be composed of 165 HCV-infected people who are also HIV infected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 165 HCV-monoinfected and 165 HIV/HCV-coinfected participants who are receiving HIV and/or HCV treatment through the VA Greater Los Angeles Health Care System, the AIDS Healthcare Foundation, or the Kaiser-Permanente Infectious Disease Program.
Key inclusion criteria (7 listed)
- Diagnosis of HCV with detectable HCV RNA in serum
- Meets clinical criteria for initiating HCV therapy
- Lives in the community and not in a board and care, nursing home, hospice, or other residential setting in which a professional caregiver would dispense necessary medication. Living with a partner, roommate, or other family members who may assist with caregiving, including reminding participants to take medication, is acceptable.
- Responsible for administering own medications
- Diagnosis of HIV-associated neurocognitive disorder (HAND) will not be cause for exclusion, so long as participant is able to demonstrate the ability to grant full informed consent
Key exclusion criteria (6 listed)
- Current or past psychotic spectrum disorder, including schizophrenia, schizophreniform disorder, or bipolar disorder
- History of learning disability, seizure disorder, closed-head injury with loss of consciousness in excess of 30 minutes, or any other neurological disease
- Evidence of any central nervous system opportunistic infection or neoplasm
- Diagnosed with Hepatitis B
- Previous failed course of HCV therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)Also: PegasysPegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV, will be given to participants. | Drug | 1, 2 |
Primary outcome
Neurobehavioral deficits as observed on neuropsychological testing in HIV/HCV-coinfected individuals before and after receiving anti-HCV treatment.
Time frame: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
2 secondary outcomes
Psychiatric symptoms
Time frame: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
Neuroimaging data (from a nested cohort of participants)
Time frame: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up
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 13 May 2016.
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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.
Charles H. Hinkin, PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis C, run by University of California, Los Angeles at 4 sites 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 7 inclusion and 6 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Neurobehavioral deficits as observed on neuropsychological testing in HIV/HCV-coinfected individuals before and after receiving anti-HCV treatment. (time frame: Measured before drug administration, Week 12 of drug administration, and Week 12 of follow-up). 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 13 May 2016.