Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
2 other identifiers
observational
2,419
1 country
2
Brief Summary
We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 1993
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedMay 7, 2026
April 20, 2026
November 3, 1999
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The purpose of this protocol is to provide a mechanism to obtain blood products and other biologic samples that will be used by NIH Intramural Investigators in studies of HIV and other infectious or immune deficiency diseases
To provide a mechanism to obtain blood products and other biologic samples that will be used by NIH Intramural Investigators in studies of HIV and other infectious or immune deficiency diseases.
Throughout
Secondary Outcomes (1)
To provide the opportunity to compare genomic and proteomic properties of specimens obtained from individuals living with HIV, other infectious diseases, and other immunodeficiencies with those of healthy volunteers
Throughout
Study Arms (3)
Individuals living with/without HIV
Individuals living with/without HIV
Individuals living with/without infectious diseases
Individuals living with/without infectious diseases of interest
Individuals with/without Immunodeficiencies
Individuals with/without immunodeficiencies
Eligibility Criteria
Volunteers living with/without HIV, Volunteers with/without immunodeficiencies, Volunteers with/without infectious diseases of interest
You may qualify if:
- years of age or older.
- Adequate venous access.
- Have a blood pressure less than or equal to 180/100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.
- Have adequate blood counts (volunteers living with HIV: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000; volunteers living without HIV: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000
- Be willing and able to provide written informed consent on screening, comply with study requirements and procedures, and comply with clinic policies
- Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, and undergo hepatitis screening
You may not qualify if:
- Pregnant and/or breastfeeding females.
- Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise volunteer safety.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
Jelicic K, Cimbro R, Nawaz F, Huang da W, Zheng X, Yang J, Lempicki RA, Pascuccio M, Van Ryk D, Schwing C, Hiatt J, Okwara N, Wei D, Roby G, David A, Hwang IY, Kehrl JH, Arthos J, Cicala C, Fauci AS. The HIV-1 envelope protein gp120 impairs B cell proliferation by inducing TGF-beta1 production and FcRL4 expression. Nat Immunol. 2013 Dec;14(12):1256-65. doi: 10.1038/ni.2746. Epub 2013 Oct 27.
PMID: 24162774BACKGROUNDLe Saout C, Hasley RB, Imamichi H, Tcheung L, Hu Z, Luckey MA, Park JH, Durum SK, Smith M, Rupert AW, Sneller MC, Lane HC, Catalfamo M. Chronic exposure to type-I IFN under lymphopenic conditions alters CD4 T cell homeostasis. PLoS Pathog. 2014 Mar 6;10(3):e1003976. doi: 10.1371/journal.ppat.1003976. eCollection 2014 Mar.
PMID: 24603698BACKGROUNDAuerbach DJ, Lin Y, Miao H, Cimbro R, Difiore MJ, Gianolini ME, Furci L, Biswas P, Fauci AS, Lusso P. Identification of the platelet-derived chemokine CXCL4/PF-4 as a broad-spectrum HIV-1 inhibitor. Proc Natl Acad Sci U S A. 2012 Jun 12;109(24):9569-74. doi: 10.1073/pnas.1207314109. Epub 2012 May 29.
PMID: 22645343BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan L Moir, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
March 9, 1993
Last Updated
May 7, 2026
Record last verified: 2026-04-20
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first.@@@@@@@@@@@@Genomic data will be shared following the guidelines of the Genomic Data Sharing Policy, when applicable.
- Access Criteria
- Identified data in BTRIS (automatic for activities in the Clinical Center and will be available for use following the BTRIS Policy for Data Sharing and Use).@@@@@@@@@@@@De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@@@@@@@De-identified genomic data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) or in NCBI Virus Portal for viral sequencing and the use of the data within will be governed by their policies.
Identified data in BTRIS (automatic for activities in the Clinical Center).@@@@@@@@@@@@De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@@@@@@@This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. De-identified data may be shared in an NIH-funded or approved public repositories, including the Database of Genotypes and Phenotypes (dbGAP) or in NCBI Virus Portal for viral sequencing.