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CompletedNCT01434563CNS HANDUpdated Oct 24, 2012

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

An observational study in HIV-1-Associated Cognitive Motor Complex, sponsored by Holdsworth House Medical Practice. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by Holdsworth House Medical Practice · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
326
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV-1-Associated Cognitive Motor Complex

Keywords

  • HIV
  • neurocognitive disorder
  • primary care
  • HIV negative
  • HAND
  • CNS
03

In context

AIDS Dementia Complex

41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.

Browse AIDS Dementia Complex studies →

Lead sponsor

Holdsworth House Medical Practice is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients attending Holdsworth House Medical Practice, Sydney, Australia

Eligibility criteria

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 , past CNS HIV-related disease, and duration of HIV therapy)
  • \<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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
326 participants (actual)

Groups and 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.

06

What researchers measure

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.

    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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2011, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2011
First posted
Sep 15, 2011
Start
Oct 2011
Primary completionActual
Oct 2012
CompletionActual
Oct 2012
Last update
Oct 24, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01434563
Lead sponsor
Holdsworth House Medical Practice
Responsible party
Dr. Mark Bloch (Doctor, Holdsworth House Medical Practice) — Principal investigator
First posted
Sep 15, 2011
Start date
Oct 2011
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Oct 24, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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