Observational Study of HIV-associated Neurocognitive Disorder (HAND2)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party)
Albert ML Anderson, Emory University
First received: September 12, 2013
Last updated: July 18, 2018
Last Verified: July 2018
History of Changes
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
HIV Associated Neurocognitive Disorder
Human Immunodeficiency Virus
Observational Model: Case-Control
Time Perspective: Prospective
|Official Title:||Observational Study of HIV-associated Neurocognitive Disorder|
Further study details as provided by Albert ML Anderson, Emory University:
Primary Outcome Measures
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 ]
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.
Biospecimen Retention: Samples Without DNA
Blood (plasma) samples and cerebrospinal fluid (CSF)
|Study Start Date:||October 2013|
|Study Completion Date:||June 5, 2018|
|Primary Completion Date:||June 5, 2018 (Final data collection date for primary outcome measure)|
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
|Ages Eligible for Study:||18 Years to 59 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
Study PopulationSubjects 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.
- Confirmed HIV infection (HAART naïve), subjects 18 to 59 years of age
- 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).
- Ongoing heavy alcohol use (more than 2 drinks per day) or ongoing illicit drug use
- Schizophrenia or other psychotic disorder, bipolar disorder, or uncontrolled depression as reported by the subject or medical provider.
- Pregnancy or incarceration
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.
Contacts and LocationsChoosing 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: NCT01966094
Locations Show More
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30308|
Sponsors and CollaboratorsEmory University
National Institute of Mental Health (NIMH)
|Responsible Party:||Albert ML Anderson, Principal Investigator, Emory University|
|ClinicalTrials.gov Identifier:||NCT01966094 History of Changes|
|Other Study ID Numbers:||IRB00065880|
|Study First Received:||September 12, 2013|
|Last Updated:||July 18, 2018|
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.