Observational Study of HIV-associated Neurocognitive Disorder (HAND2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Albert ML Anderson, Emory University
ClinicalTrials.gov Identifier:
NCT01966094
First received: September 12, 2013
Last updated: May 13, 2015
Last verified: May 2015

September 12, 2013
May 13, 2015
October 2013
October 2017   (final data collection date for primary outcome measure)
Difference in neurocognition change over 48 weeks as measured by a summary score (NPZ-8) that reflects an 8 test neurocognitive battery. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
NPZ-8 scores will be determined at each of the four visits (baseline, 12 weeks, 24 weeks, and 48 weeks). The NPZ-8 score equals the subject score minus the mean age adjusted score divided by the standard deviation of the second score.
Same as current
Complete list of historical versions of study NCT01966094 on ClinicalTrials.gov Archive Site
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Observational Study of HIV-associated Neurocognitive Disorder
Observational Study of HIV-associated Neurocognitive Disorder

It is estimated that over 1 million people in the United States have HIV infection. While HIV is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND). HAND is defined by low scores on memory testing. To meet the criteria for HAND, an HIV-infected individual has to have a low score on at least two different memory tests. It is estimated that 20-50% of people living with HIV have HAND. It is therefore still a common problem. While individuals with HAND typically improve on antiretroviral therapy for HIV, often this improvement is incomplete. Also, there are over 20 antiretroviral medications approved for HIV in the US. It is not clear if the specific choice of antiretroviral medication makes a difference in the improvement of HAND.

The investigators have designed a small preliminary study in which subjects with and without HAND who have never been on treatment for HIV or have been off treatment for at least 6 months are followed for the first 12 months after starting antiretroviral therapy.The investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will also be followed by their primary HIV medical provider. For the study, subjects will be followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks. Memory testing will be performed at baseline and each followup visit. Blood will also be taken at baseline and the three followup visits to measure changes in inflammation. A lumbar puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the last study visit of 48 weeks

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Blood (plasma) samples and cerebrospinal fluid (CSF)

Probability Sample

Subjects will be identified through referrals from HIV medical providers in the Atlanta metropolitan area. Potential subjects will be recruited from the Grady Infectious Diseases clinic as well as other clinics in the metropolitan Atlanta area, which include the Fulton and Dekalb county health departments, the Emory Infectious Diseases clinic, as well as private HIV medical practices in the area.

  • HIV Associated Neurocognitive Disorder
  • Human Immunodeficiency Virus
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  • HIV+ subjects with HAND
    Human immunodeficiency virus (HIV) positive subjects with HIV-associated neurocognitive disorder (HAND) and either antiretroviral therapy (ART) naïve or ART-experienced off treatment for at least 6 months
  • HIV+ subjects without HAND
    Human immunodeficiency virus (HIV) positive subjects without HIV-associated neurocognitive disorder (HAND) and either antiretroviral therapy (ART) naïve or ART-experienced off treatment for at least 6 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
June 2018
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed HIV infection (HAART naïve), subjects 18 to 59 years of age
  2. Negative serum cryptococcal antigen if CD4+ T-cell count <100 cells/microliter, normal serum thyroid stimulating hormone level, negative serum rapid plasma reagin (RPR) (Can have positive RPR ≤1:4 if treated for syphilis by CDC guidelines at least 6 months prior to enrollment, had no signs/symptoms of neurosyphilis, and RPR titer decreased at least 4-fold by 6 months after treatment).

Exclusion Criteria:

  1. Ongoing heavy alcohol use (more than 2 drinks per day) or ongoing illicit drug use
  2. Schizophrenia or other psychotic disorder, bipolar disorder, or uncontrolled depression as reported by the subject or medical provider.

3 Neoplasm of the CNS OR history of traumatic brain injury with loss of consciousness > 30 minutes OR CNS infection in the last 6 months.

4. Pregnancy or incarceration

Both
18 Years to 59 Years
No
United States
 
NCT01966094
IRB00065880, K23MH095679
Yes
Albert ML Anderson, Emory University
Emory University
National Institute of Mental Health (NIMH)
Not Provided
Emory University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP