Trial record 11 of 41 for:    " August 31, 2011":" September 30, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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:
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
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

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
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Holdsworth House Medical Practice:
HIV
neurocognitive disorder
primary care
HIV negative
HAND
CNS

Additional relevant MeSH terms:
HIV Infections
AIDS Dementia Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014