Status:

COMPLETED

Mental Ability Challenge Study in Adults With and Without HIV

Lead Sponsor:

Vanderbilt University Medical Center

Conditions:

HIV-1-infection

Aging, Premature

Eligibility:

All Genders

35+ years

Brief Summary

It is estimated that by 2016, nearly 50% of HIV-positive individuals in the US will be aged 50 or older, and up to 60% of those will experience some degree of cognitive impairment as they age. The pur...

Detailed Description

This study is intended to evaluate the involvement of the neuronal cholinergic receptor system in the accelerated cognitive aging profile seen in adults living with chronic HIV-1 infection. It is esti...

Eligibility Criteria

Inclusion

  • 35 years of age or older;
  • HIV-Positive (must be on ART's for at least 6 months, most recent viral load (within 6 months) \<50, CD4+ count \>200, must be diagnosed HIV-positive at least 5 years) or HIV-Negative, At-Risk Individuals
  • Able and willing to give written informed consent
  • Negative urine pregnancy test
  • Adequate visual and auditory acuity to allow neuropsychological testing.

Exclusion

  • Unmanaged HIV Infection, identified by no current medication regimen or the presence of one or more AIDS-defining conditions
  • Fagerstrom cigarettes per day (CPD) score of '2' indicating heavy use of nicotine
  • An ART regimen including a Protease Inhibitor Medication
  • A documented history of cardiac disease or abnormal ECG at Screening
  • Current alcohol or substance abuse, particularly intravenously
  • Current use of psychoactive medications (antipsychotics, benzodiazepines, etc.)
  • Current Axis I or Axis II psychiatric disorder
  • History of myocardial infarction in the past year or unstable or severe cardiovascular disease

Key Trial Info

Start Date :

December 1 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2018

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT03244488

Start Date

December 1 2015

End Date

December 1 2018

Last Update

February 25 2019

Active Locations (1)

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1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212