ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT0000128191014091-I-0140NCT00001281Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIVStudies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIVNational Institute of Allergy and Infectious Diseases (NIAID)NIHMedstar Health Research InstituteOtherNoNo
The purpose of this this study is to learn more about the immune system, how it responds to
infections (like HIV) and to learn more about conditions that may decrease your immune system
s ability to fight infections. The primary procedure to be performed is venipuncture and
blood drawing. The blood will be used for a variety of studies looking at immune dysfunctions
and at the effects of HIV or other infectious and noninfectious conditions on the production
of factors by immune cells. In addition, the cells in the blood may be screened for genes
that have missing pieces or changes in them that can affect their function. This will help us
evaluate specific immune responses for research purposes. This study will examine the effects
of HIV infection on substances produced by immune cells that increase or decrease HIV
infection.
Both people living with and without HIV may be eligible for this study. Participants will be
required to have a yearly medical evaluation, including blood tests for cell counts and
chemistries, a blood or urine pregnancy test for women, and other laboratory tests as
medically indicated or for research purposes.
Participants will donate blood or reproductive fluids, or both. From 20 to 150 cc (4 to 30
teaspoonfuls) of blood will be drawn from the arm using a small needle. Participants may be
asked to provide blood samples on more than one occasion over the course of the study. No
more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Males
will be given a private room for semen donation; fluid from females will be collected with a
cotton swab after speculum insertion. Participants may also be asked to have a buccal swab.
For this procedure, the inside of the cheek is gently scraped with a blunt-ended stick or
brush to obtain cells (buccal mucosal cells). The tissues will be used for a variety of
studies on the effects of HIV infection on factors that increase or decrease HIV infection.
Some of the tissues collected for this study may also be used for the following tests:
- Hepatitis screening Blood may be screened for different types of viral liver infections,
such as hepatitis A, B, C, D, E, or G.
- Genetic testing We will use genetic tests that focus on specific genes that can affect
how the immune system works or to learn more about HIV and other conditions being
studied. We may test the DNA in the cells in the blood or in cheek cells for the
presence of mutations or deletions. These alterations may be sought in genes encoding
factors that are linked to the immune system s ability to fight infection and prevent
disease, or factors that allow HIV and other infectious agents to cause infection. from
blood or cheek cells may be examined for mutations or deletions that affect chemokines,
cytokines and a family of enzymes called caspases. Chemokines and cytokines are
important mediators of the immune response. Alterations in the genes for some of these
substances influence HIV infection.
- HLA testing Blood may be tested for HLA type-a genetic marker of the immune system.
These tests may be used to try to identify factors associated with the rate of
progression of HIV disease or related conditions. Determining HLA type is necessary to
be able to perform certain research studies. Some HLA types have been associated with an
increased risk of certain diseases like arthritis and other rheumatologic problems.
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.
RecruitingMarch 9, 1993ObservationalNoCohortProspectiveThe 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 diseasesThroughoutTo 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 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 volunteersThroughoutTo 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 volunteers42500HIVImmunodeficienciesInfectious DiseasesIndividuals living with HIVIndividuals living with HIVIndividuals living with/without HIVIndividuals living with/without HIVIndividuals living with/without infectious diseasesIndividuals living with/without infectious diseases of interestIndividuals with/without ImmunodeficienciesIndividuals with/without immunodeficiencies
Volunteers living with/without HIV, Volunteers with/without immunodeficiencies, Volunteers
with/without infectious diseases of interest
Non-Probability Sample
- INCLUSION CRITERIA:
- 18 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
EXCLUSION CRITERIA:
- Pregnant and/or breastfeeding females.
- Active substance abuse or history of prior substance abuse that may interfere with
protocol compliance or compromise patient safety.
All18 Years120 YearsAccepts Healthy VolunteersSusan Moir, Ph.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)Catherine A Seamon, R.N.(301) 402-3481cseamon@cc.nih.govSusan Moir, Ph.D.(301) 402-4559sm221a@nih.govWashington Hospital CenterWashingtonDistrict of Columbia20010United StatesCompletedNational Institutes of Health Clinical CenterBethesdaMaryland20892United StatesRecruitingFor more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)800-411-1222TTY dial 711ccopr@nih.govUnited Stateshttps://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1991-I-0140.htmlNIH Clinical Center Detailed Web PageJelicic 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 27.24162774Le 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.24603698Auerbach 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 29.22645343February 9, 2024November 3, 1999November 3, 1999November 4, 1999March 14, 2024March 14, 2024March 15, 2024SponsorLymphocytesVenipunctureMononuclear CellsNatural HistoryInfectionsHIV InfectionsCommunicable DiseasesYes.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.Study ProtocolShared 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.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.