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
  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 Phase
HIV Associated Neurocognitive Disorder
Human Immunodeficiency Virus
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of HIV-associated Neurocognitive Disorder

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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.


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)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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.

4. Pregnancy or incarceration

  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
  More Information

No publications provided

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: May 13, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2015