F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected

Sponsor

Tammie L. S. Benzinger, MD, PhD (Other)

Overall Status

Completed

CT.gov ID

NCT03279523

Collaborator

(none)

Enrollment

Location

24.6

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as 7-(6-fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole), a novel tau imaging compound, in older HIV+ individuals with and without HAND and matched HIV uninfected (HIV-) controls. The primary goal is to develop this highly promising tau imaging technique as an biomarker of cognitive decline in HIV+ individuals. The investigators will obtain preliminary data that will support the possibility of detecting early brain pathological changes due to HIV. Data generated from this study will be used for submission of National Institutes of Health (NIH) grants comparing tau deposition in HAND compared to other neurodegenerative disorders. It is hypothesized that specific topographies will help distinguish these neurodegenerative disorders in older individuals.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease HIV	Drug: F 18 T807

Detailed Description

This protocol will demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls.

It will also demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals.

The investigtors hypothesize that in vivo tau imaging will ultimately:

Demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls.
Demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals.

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)

Actual Study Start Date :

May 3, 2016

Actual Primary Completion Date :

May 23, 2018

Actual Study Completion Date :

May 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
F 18 T807 Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.	Drug: F 18 T807 Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. Other Names: 18F-AV-1451

Arm

Intervention/Treatment

F 18 T807

Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.

Drug: F 18 T807

Other Names:

18F-AV-1451

Outcome Measures

Primary Outcome Measures

Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls. [5 years]

Secondary Outcome Measures

: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants, ≥ 40 years of age.
Testing for HIV status. If positive will be included in the HIV+ group and if negative will be included in the HIV- group.
Females without documented history of menopause or hysterectomy will undergo a urine pregnancy test 24 hours prior to F 18 T807 drug administration.

Exclusion Criteria:

Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
Is deemed likely unable to perform the imaging procedures for any reason.
Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
Has hypersensitivity to F 18 T807 or any of its excipients.
Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
Severe claustrophobia.
Currently pregnant or breast-feeding.