NCT00959166

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

August 13, 2009

Results QC Date

September 24, 2019

Last Update Submit

October 21, 2019

Conditions

Acute Hepatitis CHIVHIV Infections

Keywords

Acute hepatitis CHIVNeurocognitive functionNeuroinflammation

Outcome Measures

Primary Outcomes (1)

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

    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.

    30 days

Secondary Outcomes (1)

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

    30 days

Study Arms (2)

HIV/acute HCV coinfection

OTHER

Subjects with HIV/acute HCV coinfection (aHCV cases) were required to have acute HCV, defined by a new positive plasma HCV RNA test within 12 months of a negative HCV RNA test.

Other: PET scan

HIV mono

OTHER

HIV-infected individuals without hepatitis C co-infection

Other: PET scan

Interventions

PET scanOTHER

PET brain scan

HIV monoHIV/acute HCV coinfection

Eligibility Criteria

Age25 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Garvey LJ, Pavese N, Ramlackhansingh A, Thomson E, Allsop JM, Politis M, Kulasegaram R, Main J, Brooks DJ, Taylor-Robinson SD, Winston A. Acute HCV/HIV coinfection is associated with cognitive dysfunction and cerebral metabolite disturbance, but not increased microglial cell activation. PLoS One. 2012;7(7):e38980. doi: 10.1371/journal.pone.0038980. Epub 2012 Jul 12.

    PMID: 22808022RESULT

MeSH Terms

Conditions

HIV InfectionsNeuroinflammatory Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Prof Alan Winston
Organization
Imperial College London
a.winston@imperial.ac.uk
+44 (0)20 3312 1603

Study Officials

  • Alan Winston

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

October 22, 2019

Results First Posted

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)