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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Holdsworth House Medical Practice


Information provided by (Responsible Party)
Dr. Mark Bloch, Holdsworth House Medical Practice

ClinicalTrials.gov Identifier
NCT01434563

First received: September 14, 2011
Last updated: October 22, 2012
Last Verified: October 2012
History of Changes
Purpose

Purpose

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.

Condition
HIV-1-Associated Cognitive Motor Complex

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort

Further study details as provided by Dr. Mark Bloch, Holdsworth House Medical Practice:

Primary Outcome Measures

  • 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.

Enrollment: 326
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Arms
HIV positive
Subjects must have documented HIV, be english speaking, with life expectancy greater than 6 months, and must have adequate information available in their medical record to apply HAND predictive algorithm (HIV-associated neurological disease)
HIV negative
Must have documented negative HIV test within 12 months of study entry, have no traumatic brain injury or history of chronic neurological illness/psychiatric conditions (such as bipolar or depression),be english speaking and have no history of drug or alcohol abuse.
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

Patients attending Holdsworth House Medical Practice, Sydney, Australia

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434563

Sponsors and Collaborators

Holdsworth House Medical Practice
More Information

More Information


Responsible Party: Dr. Mark Bloch, Doctor, Holdsworth House Medical Practice  
ClinicalTrials.gov Identifier: NCT01434563   History of Changes  
Other Study ID Numbers: CNS HAND Study  
Study First Received: September 14, 2011  
Last Updated: October 22, 2012  

Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:

HIV
neurocognitive disorder
primary care
HIV negative
HAND
CNS

Additional relevant MeSH terms:
Neurocognitive Disorders
AIDS Dementia Complex

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.