Skip to main content
OpenTrials
Completed

NCT Number: NCT01434563

The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -

To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population. The investigators aim is to assess the use of optimal screening methods to assess HAND. For this the investigators will be comparing the performance of a group of persons who are HIV positive and a group of persons who are HIV negative to test their memory and concentration abilities over-time.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

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

HIV positive Inclusion Criteria:

  • Documented HIV infection
  • Able to participate in study procedures

HIV positive Exclusion Criteria:

  • Inability to comprehend or read English (as established by the English proficiency questionnaire)
  • Drug or alcohol intoxicated (as determined by the investigator)
  • Lack of information in medical records to determine the HAND predictive algorithm (current CD4 count, past CNS HIV-related disease, and duration of HIV therapy)
  • Life expectancy <6 months
  • Inability to attend the clinic for required study follow up visits

HIV-negative Inclusion Criteria:

  • Negative HIV-1 test within 12 months of study entry

HIV-negative Exclusion Criteria:

  • Life time traumatic brain injury leading to loss of consciousness of at least 30 minutes.
  • Inability to comprehend or read English (as established by the English proficiency questionnaire).
  • Inability to attend the clinic for required study follow up visits.
  • History of chronic neurological illness.
  • Unstable psychiatric conditions such as bipolar disorder or depression.
  • Individuals with psychiatric disorder on the psychotic axis.
  • Active or past (within the last 6 months) severe alcohol or substance abuse sufficient, in the investigator's judgement, to prevent completion of tests or Inability to attend for the planned required study follow up visits.

Treatment and study plan

Primary outcomes

  1. The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.

    Time frame: 12 months

    The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Registry information

Official study title

The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort

Acronym: CNS HAND

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2011
Registry last updated
Oct 24, 2012

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.

Published trials that share one or more normalized conditions with this study.