Purpose

HIV-Associated Neurocognitive Disorders (HANDs) are a pervasive and debilitating complication of HIV infection with an estimated prevalence of 30-45%. The identification of robust validated specific and sensitive biomarkers for HAND that do not require invasive CSF sampling has been elusive and is of paramount importance. However unrecognized racial differences in gene expression could significantly impact the predictive value of biomarkers of HAND if applied to populations in which they have not been developed or validated. We hypothesize that significant racial differences will be identified in the peripheral blood single-cell based gene-expression profiles of HAND. We further hypothesize that these differences may be largely attributed to delays in viral suppression and delayed/decreased access to care. To test these hypotheses we will use multivariate modeling to determine the relative influence of clinical and sociodemographic variables and social determinants of health on unbiased single-cell based gene transcriptional profiles in the peripheral blood of HIV-positive virally suppressed African American and Caucasian cohorts with and without HAND.

Condition

Eligibility

Eligible Ages
Between 18 and 74
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Non-Hispanic HIV positive African American or Caucasian individuals 18 - 74 years of age male or female OR Non-Hispanic HIV negative African American or Caucasian individuals 18-74 years of age male or female
  • For both HIV negative and HIV positive participants: English language fluency
  • For HIV negative and HIV positive participants: Ability and willingness of participant to give written informed consent
  • For both HIV negative and HIV positive participants: If female negative Beta-HCG (human chorionic gonadotropin) pregnancy test
  • For both HIV negative and HIV positive participants: Agrees to have blood samples collected for research purposes
  • For HIV negative participants: Non-reactive HIV test at screening/enrollment
  • For HIV positive participants: Positive HIV-1 serology treatment for at least one year with combination antiretroviral therapy plasma HIV-1 RNA levels below 50 copies/ml for at least 6 months prior to screen visit as evidenced by lab results from their primary care provider

Exclusion Criteria

  • Bleeding diathesis or current use of anticoagulants
  • History of head injury with loss of consciousness greater than thirty minutes
  • History of severe neurological (e.g. multiple sclerosis seizure disorder) or Diagnostic and Statistical Manual Five Edition (DSM-V) pschyiatric illness that affects cognitive functioning (e.g. schizophrenia biopolar affective disorder)
  • Current diagnosis of major depression disorder as assessed by the patient health questionnaire nine item depression scale (PHQ-9) and not on stable antidepressant medication > 30 days
  • DSM-V criteria for severe alcohol/substance use disorder within 1 year prior to screen (excluding marijuana)
  • History of clinically significant cardiac disease such as myocardial infarction congestive heart failure or cardiac arrhythmia requiring treatment moderate-severe atherosclerosis
  • Significant renal disease poorly controlled diabetes autoimmune disorders chronic inflammatory disease
  • Any other clinical conditions or prior to enrollment treatment in the opinion of the investigator would make the subject unsuitable for the study or unable to comply with the requirements of the protocol
  • Laboratory values obtained within 45 days prior to study entry: PT/PTT > 1.5 x control Positive Hepatitis C antibody (HepC Ab+) Positive Hepatitis B surface antigen (Hbs Ag+) Absolute neutrophill count (ANC) < 500 cells/mm3 Platelet count < 80000/mm3 Hemoglobin < 9.0 g/dl Calculated creatinine clearance < 55 mL/minute AST (SGOT) ALT (SGPT) or alkaline phosphatase > 5.0 times the upper limit of normal (ULN) Total bilirubin > 2.5 x ULN (isolated Bilirubin > 2 x ULN is acceptable if direct Bilirubin is < 35%
  • Serologic evidence of untreated syphilis
  • Prolonged steriod/hormonal replacement therapy (physician-prescribed testosterone-replacement therapy in men excluded)

Study Design

Phase
Study Type
Observational

More Details

Status
Recruiting
Sponsor
Rockefeller University

Study Contact

Recruitment Office
8007822737
rucares@rockefeller.edu

Notice

Study information shown on this site is derived from this institution's local clinical trials team. The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.