Observational Study of HIV-associated Neurocognitive Disorder
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 7/21/2018 |
| Start Date: | October 2013 |
| End Date: | June 5, 2018 |
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
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
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
We found this trial at
1
site
1648 Pierce Dr NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-616-3147
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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