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Completed

NCT Number: NCT00959166

To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals:

* Group 1: Individuals with HIV infection and acute (early) hepatitis C infection * Group 2: Individuals with HIV infection * Group 3: Healthy volunteers

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Key information

Conditions

Acute Hepatitis C Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

25 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's Hospital

London, W2 1NY, United Kingdom

About this study

Subtle changes to the brain, which doctors find difficult to detect through conversation or examination, may occur in patients with HIV and/or hepatitis C infection. It is not currently known whether the brain is affected in early (or acute) hepatitis C.

Individuals wishing to take part will complete a series of tests assessing different aspects of their brain including:

  • 2 brain scans using different technology:
  • Magnetic resonance imaging (MRI) brain scan with spectroscopy
  • CT PET brain scan
  • A computer game test which measures brain function
  • 2 short questionnaires

Results of these tests will be analyzed and compared between 3 groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 antibody positive for at least 12 months
  • Acute HCV (Blood HCV PCR positive with negative PCR within past 8 months)
  • HCV genotype 1
  • Ability to give informed consent
  • Aged > 25 years
  • Male
  • Abbreviated Mental Test Score of at least 8/10

Exclusion criteria

  • Evidence of established cirrhosis or encephalopathy
  • Commencing or any change to HIV medications within 12 weeks
  • Active opportunistic infection
  • Taking anti-depressants or any psychoactive medications within past 4 weeks
  • Use of benzodiazepines within past 4 weeks
  • Recent significant head injury
  • Established dementia
  • Alcohol dependence or recreational drug misuse
  • Untreated early syphilis
  • Hepatitis B infection (HBsAg positive)
  • Pregnancy
  • Unable to give informed consent
  • Any contraindication to MR scanning

Treatment and study plan

PET Scan

Other

PET brain scan

Primary outcomes

  1. Association of 11C-labelled PK11195 Uptake Using PET With Acute HCV and HIV Infection

    Time frame: 30 days

    Association of 11C-labelled PK11195 uptake using PET with acute HCV and HIV infection by PK11195 PET ligand binding. The ligand PK11195 is selective for the peripheral benzodiazepine binding site and exhibits minimal binding in normal brain. In brain lesions, however, there is a massive increase in binding.

Secondary outcomes

  1. Ratio of NAA/Cr (N-acetyl Aspartate/Creatine) Cerebral Metabolites

    Time frame: 30 days

    Association between patient characteristics and 11C-labelled PK11195 uptake using PET, CNS metabolite ratios.

    By quantifying the surrogate markers of N-acetylaspartate (NAA), creatine (Cr) offers insight into the neuronal integrity, cell membrane synthesis and turnover, macrophage infiltration, inflammation status, and levels of microglial activation and gliosis within the sampled CNS tissue.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

A Prospective Case-control Study to Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-infection - a PET Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 14, 2009
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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