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(TEV-0924) Role of alpha4 beta 1 integrin (VLA-4) in HAND

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Discovering novel therapeutic options for HIV-Associated Neurocognitive Disorders (HAND) by exploiting the role of the alpha4 beta1 integrin (VLA-4)

Principal Investigator:
Teresa Evering M.D.

Martin H. Markowitz M.D.

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7722
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
HIV-Associated Neurocognitive Disorders (HANDs) are an important possible clinical complication of HIV infection and can result in problems with behavior, movement and the ability to think and reason. Although combination antiretroviral therapy (cART) for HIV exists, the frequency of HANDs is 30% to 50%. At this time, no other therapies for HAND exist beyond cART, making the need for their development highly necessary. Researchers at the Rockefeller University Hospital want to learn more about how in HIV infection, cells of the immune system which are infected with HIV cross the blood brain barrier and cause injury and damage to cells in the brain. This damage might result in the development of HAND which leads to an increased decline in the neurocognitive ability of some HIV-infected. By obtaining blood and cerebrospinal fluid (CSF)from individuals who are HIV-infected with HAND and those HIV-infected without HAND as compared to HIV-uninfected individuals, the researchers may be able to identify the types of genes (basic units of heredity) in immune cells that are responsible for cellular damage and neurocognitive decline. This in turn may lead to the development of therapeutic agents that can block this damage. We are asking you to take part in this research study if you are between 18 and 74 years of age, HIV-negative or HIV-infected on combination antiretroviral therapy for at least a year with an undetectable viral load. All individuals will be asked to undergo blood draws, a lumbar puncture procedure, neuropsychological testing, and complete health-related questionnaires. Individuals who participated in a study involving neuropsychological testing(TEV-0917) within the past 3 months may participate in this study and the neuropsychological testing will not be repeated.

Detailed Description of Protocol:

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- 18-74
- HIV-positive cohort: On treatment for at least 1 year
- Never had a diagnosis of Hepatitis B or C



Children permitted to participate:

Potential Benefits.....
The benefit for the individual subject for participating in this study will include a complete physical exam, routine blood test results, screening for Hepatitis B and C, HIV testing (if you are an HIV- individual and HIV-1 Viral load and CD4+ T cell count if you are an HIV+ individual at no cost to you. If any clinically significant abnormalities are found during these evaluations, we will recommend that you see your primary care provider for a full evaluation. In addition, others may benefit in the future from what we learn from this study.

Compensation is provided