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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00747539 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV) |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Neurobehavioral Deficits in HIV/HCV Infection Pre/Post Anti-HCV Therapy |
Urine samples will be collected.
Estimated Enrollment: | 330 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
This group will be composed of 165 HCV-infected people who are not also HIV infected.
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Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)
Pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV, will be given to participants.
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2
This group will be composed of 165 HCV-infected people who are also HIV infected.
|
Drug: Pegylated interferon alfa and ribavirin (PEG-IFN/RBV)
Pegylated interferon alfa and ribavirin (PEG-IFN/RBV), considered standard care for patients with chronic HCV, will be given to participants.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Gabriel Waterman | 310-268-3680 | Gabriel.Waterman@va.gov |
Contact: Michelle Kim | 310-268-4414 | Michelle.Kim@va.gov |
United States, California | |
Veterans Administration Greater Los Angeles Healthcare System | Recruiting |
Los Angeles, California, United States, 90073 | |
Contact: Gabriel Waterman 310-268-3680 Gabriel.Waterman@va.gov | |
Contact: Michelle Kim 310-268-4414 Michelle.Kim@va.gov | |
Sub-Investigator: Neville R. Pimstone, MD | |
Sub-Investigator: Jason Smith, PharmD | |
Sub-Investigator: Matthew Goetz, MD | |
University of California, Los Angeles, School of Medicine | Recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Charles H. Hinkin, PhD 310-268-4357 chinkin@ucla.edu | |
Principal Investigator: Charles H. Hinkin, PhD | |
Sub-Investigator: Steven Castellon, PhD | |
Sub-Investigator: Michael A. Thomas, PhD | |
Kaiser Permanente Infectious Diseases, Antelope Valley | Recruiting |
Lancaster, California, United States, 93534 | |
Contact: Jonathan T. Truong, MD 661-726-2140 Jonathan.T.Truong@kp.org | |
Sub-Investigator: Jonathan T. Truong, MD | |
AIDS Healthcare Foundation | Recruiting |
Los Angeles, California, United States, 90028 | |
Contact: Homayoon Khanlou, MD 323-860-5200 Homayoon.Khanlou@aidshealth.org | |
Sub-Investigator: Homayoon Khanlou, MD | |
Sub-Investigator: Laveeza Bhatti, MD |
Principal Investigator: | Charles H. Hinkin, PhD | University of California, Los Angeles |
Responsible Party: | UCLA School of Medicine ( Charles H. Hinkin, PhD ) |
Study ID Numbers: | R01 MH083553, DAHBR 9A-ASNM |
Study First Received: | September 4, 2008 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00747539 History of Changes |
Health Authority: | United States: Federal Government |
Hepatitis C Virus HCV Human Immunodeficiency Virus Coinfection |
Antimetabolites Interferon-alpha Anti-Infective Agents Sexually Transmitted Diseases, Viral Immunologic Factors Interferons Acquired Immunodeficiency Syndrome Ribavirin Angiogenesis Inhibitors Antiviral Agents |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases HIV Infections Sexually Transmitted Diseases Peginterferon alfa-2a Hepatitis C Antibodies Hepatitis C Interferon Alfa-2a Retroviridae Infections |
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Infection Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections |
Interferon-alpha RNA Virus Infections Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Interferon Alfa-2a |