HIV AGING AND COGNITION: A SYNERGISM - REPOSITORY STUDY

Lundquist Institute For Biomedical Innovation At Harbor-Ucla Medical Center, Torrance CA

Investigators

Linked publications & trials

Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to compare the frequency, nature and severity of cognitive impairment (e.g., memory;attention);neurocognitive disorders;and functional status between younger (18-39 years) and older (50 years and older) individuals infected with HIV (Human Immunodeficiency Virus) in its symptomatic stages. The relationship of aging to plasma viral load and to immunological decrements over time will also be assessed. This study will establish a repository at CSMC for plasma and peripheral blood mononuclear cells (PBMCs), urine specimen, and cervical tissue for the "HIV and Aging" (Pro00012492) IRB approved study. The repository's focus will be to provide information on the frequency, nature and severity of problems in cognition (e.g., memory;attention) that occur in younger (18-39 years) [n=20] and older (50 years and older) [n=20] individuals infected with HIV. HIV negative individuals in the same younger [n=20] and older [n=20] age groups are asked to participate as controls. This repository will be established for the investigation of the relationship between cognition and clinical laboratory progression measures in the blood that are markers of HIV clinical progression. Information may be obtained that will serve as predictors for the subsequent development of cognitive problems in older vs. younger HIV+ persons. These predictors will also potentially include genetic markers. Blood samples will be drawn for a total of 120ml over the course of the study. 40ml will be collected at the baseline visit, and 40 ml will be collected at the two annual follow-up visits. Part of the specimens will sent to UCLA for later virologic assays to be conducted en masse. It will not be necessary to share identifiable PHI with investigators at UCLA. No specimens will be sent from UCLA to CSMC. UCLA investigators will not interact with subjects, either here or at UCLA, for the purposes of this research. Also, CSMC investigators will not interact with subjects at UCLA for the purposes of this research. The samples to be sent to UCLA are 2 10 ml. tubes of peripheral blood from aging study participants in which PBMCs will be isolated. The remaining 20 ml are for long-term storage for other future, yet-to-be-planned assays. The urine and cervical tissue (from the Pap smear) specimens will be collected under the Aging Study and will be included as remnant samples. Cerebrospinal fluid was collected under previously approved protocols for this repository and will be maintained in this repository. The remainder of the samples (serum, plasma, and CSF) from the NIMH repository for one of these prior protocols (the NIMH's Peptide T Trial) will be transferred to CSMC. This is a continuation of a research project initiated at the University of Miami, where 279 subjects were previously enrolled. 80 more subjects will be recruited at CSMC. Data collected from participants at the University of Miami will be incorporated as part of the research conducted at CSMC. A plasma and peripheral blood mononuclear cell (PBMC) repository was included from the inception of the NIH-funded research project and will be necessary to continue in order for the renewal from which it is hoped that novel studies may be performed to further generate data beyond the scope of the actual proposal itself on the basis of the funding for this research. PBMCs will be stored to provide future resources to explore other important measures. This repository will be maintained at CSMC only. There are no collaborating repository sites, and the University of Miami will no longer be involved as a site of the study. Study investigators to be included from this point onward will be from CSMC and UCLA (working on sub-contract to CSMC). The University of Miami has been so notified, and the study was closed with the University of Miami IRB upon the PI[unreadable]s departure from that institution. This repository will also contain de-identified samples that can be used to address questions related to the presence/absence of HIV from the University of Miami collected by Dr. Goodkin during three previous NIH-funded research studies. The entire repository will be maintained and monitored by the parent HIV &Aging Study Investigators of protocol 12492. (AME 7646) REGARDING NIMH SAMPLES WHICH WILL BE TRANSFERRED TO CSMC : The Deputy Director of the NIMH AIDS Program Office, Dr. Dianne Rausch, requested that the PI maintain the remainder of the repository from that trial for the NIMH and that the samples be transferred from the NIMH's repository site to CSMC. The proposed CSMC repository addition from NIMH consists solely of plasma, serum, and CSF samples (which are the same tissue types originally included in the current repository from that trial). - No personal identifiers will be associated with the samples to be transferred. - The information that will be associated with the samples being transferred from the NIMH's repository will be coded. - CSMC investigators will not have access to the linking list associated with information from other study sites. -The researchers at this site have access solely to the linking list for those participants that were recruited at the PI's prior institution. [The study was completed before the PI moved to CSMC in 2007]. The specific aims for the HIV &Aging study samples are: Plasma, peripheral blood mononuclear cells, and remnant samples of urine and cervicel smears will be added to the previously stored samples to provide future resources to explore other measures related to HIV and aging, such as T cell receptor excision circles (TRECs), which may explain an interaction between thymic involution with older age and decreased thymic emigrants as well as long-term immune reconstitution with highly active antiretroviral therapy (known as "HAART"). It is anticipated that novel studies may be performed to further generate data beyond the scope of the actual proposal itself on the basis of this repository. In addition, the existing plasma, PBMCs, urine, CSF and cervical smears from the three prior NIMH HIV/AIDS studies of the PI will continue to be retained for questions related to the presence/absence and impact of HIV infection. The remainder of the samples (serum, plasma, and CSF) from the NIMH repository for one of these NIMH HIV/AIDS prior protocols (the NIMH's Peptide T Trial) will be transferred to CSMC.