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

HIV-1-Associated Cognitive Motor Complex Clinical Trial

— CNS HAND  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434563
• Other study ID #: CNS HAND Study
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: October 22, 2012
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS Dementia Complex
• HIV-1-Associated Cognitive Motor Complex

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	12 months	No