NCT00494936

Brief Summary

This study will determine the effects that HIV and hepatitis C virus have on thinking abilities and whether the viruses affect brain chemistry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

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

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

June 28, 2007

Last Update Submit

May 21, 2015

Conditions

HIV InfectionsHepatitis C

Keywords

HIVHCVTreatment NaiveTreatment ExperiencedHIV and HCV Coinfection

Study Arms (4)

HIV/HCV

HIV and HCV coinfected

HIV infected

HIV monoinfected

HIV/HCV nonviremnic

HIV and HCV coinfected with HCV RNA less than 600 copies

HCV infected

HCV monoinfected with HCV viremia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV / HCV Coinfected, HIV moninfected, \& HCV monoinfected

You may qualify if:

  • CD4 count is greater than 200
  • Hepatitis C infected or uninfected
  • Speaks English

You may not qualify if:

  • Currently receiving interferon treatment for hepatitis C
  • History of neurological illness
  • Any psychotic spectrum disorder (e.g., schizophrenia or manic depression/bipolar disorder)
  • History of learning disability
  • History of head injury that entailed a loss of consciousness for more than 30 minutes
  • Any metal in body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Related Publications (1)

  • Ryan EL, Morgello S, Isaacs K, Naseer M, Gerits P; Manhattan HIV Brain Bank. Neuropsychiatric impact of hepatitis C on advanced HIV. Neurology. 2004 Mar 23;62(6):957-62. doi: 10.1212/01.wnl.0000115177.74976.6c.

    PMID: 15037699BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Elizabeth Ryan, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

May 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

US(1)