Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV

NCT ID: NCT00001281

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2419 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-03-09

Brief Summary

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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....

Detailed Description

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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.

Conditions

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HIV Immunodeficiencies Infectious Diseases

Keywords

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Lymphocytes Venipuncture Mononuclear Cells Natural History

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals living with/without HIV

Individuals living with/without HIV

No interventions assigned to this group

Individuals living with/without infectious diseases

Individuals living with/without infectious diseases of interest

No interventions assigned to this group

Individuals with/without Immunodeficiencies

Individuals with/without immunodeficiencies

No interventions assigned to this group

Eligibility Criteria

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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 volunteer safety.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan L Moir, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

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Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status COMPLETED

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine A Seamon, R.N.

Role: CONTACT

Phone: (301) 402-3481

Email: [email protected]

Susan L Moir, Ph.D.

Role: CONTACT

Phone: (301) 402-4559

Email: [email protected]

Facility Contacts

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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24162774 (View on PubMed)

Le 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.

Reference Type BACKGROUND
PMID: 24603698 (View on PubMed)

Auerbach 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.

Reference Type BACKGROUND
PMID: 22645343 (View on PubMed)

Related Links

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Other Identifiers

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910140

Identifier Type: -

Identifier Source: org_study_id

91-I-0140

Identifier Type: -

Identifier Source: secondary_id