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Clinical Trials

MainTitle

Observational Study of HIV-associated Neurocognitive Disorder (HAND2)

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2017 by Albert ML Anderson, Emory University

Sponsor
Emory University

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
Albert ML Anderson, Emory University

ClinicalTrials.gov Identifier
NCT01966094

First received: September 12, 2013
Last updated: July 25, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

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

Condition
HIV Associated Neurocognitive Disorder
Human Immunodeficiency Virus

Study Type: Observational
Study Design: 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)

Estimated Enrollment: 46
Study Start Date: October 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Arms
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
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 59 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

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.

Criteria

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.
  1. Pregnancy or incarceration

contacts and locations

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966094

Locations

United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30308
Contact: Albert Anderson, MD    404-616-3147

Sponsors and Collaborators

Emory University
National Institute of Mental Health (NIMH)
More Information

More Information


Responsible Party: Albert ML Anderson, Principal Investigator, Emory University  
ClinicalTrials.gov Identifier: NCT01966094   History of Changes  
Other Study ID Numbers: IRB00065880  
  K23MH095679  
Study First Received: September 12, 2013  
Last Updated: July 25, 2017  

Additional relevant MeSH terms:
Disease
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Neurocognitive Disorders

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.