Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons
Study Details
Study Description
Brief Summary
This study will examine the effects of HIV infection on substances produced by immune cells that increase or decrease HIV infection.
HIV-infected patients and healthy normal volunteers 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:
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Hepatitis screening Blood may be screened for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G.
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Genetic testing DNA 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. Caspases regulate the process of cell death, known as apoptosis. Caspase gene variations may determine the rate of cell death in HIV-infected persons, and therefore, the rate of HIV progression. Patients with abnormalities of any of these genes may be invited to join other studies of the role of genetic defects in HIV infection.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HIV Infected Individuals HIV infected Individuals |
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| HIV Uninfected Individuals HIV uninfected Individuals |
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| Individuals with/without Immunodeficiencies Individuals with/without immunodeficiencies |
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| Individuals with/without infectious diseases Individuals with/without infectious diseases of interest |
Outcome Measures
Primary Outcome Measures
- 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 [Throughout]
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.
Secondary Outcome Measures
- To provide the opportunity to compare genomic and proteomic properties of specimens obtained from individuals with HIV , other infectious diseases, and other immunodeficiencies with those of healthy volunteers [Throughout]
To provide the opportunity to compare genomic and proteomic properties of specimens obtained from individuals with HIV, other infectious diseases, and other immunodeficiencies with those of healthy volunteers
Eligibility Criteria
Criteria
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INCLUSION CRITERIA:
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18 years of age or older.
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Adequate venous access.
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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.
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Have adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000; HIV negative volunteers: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000)
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Be willing and able to provide written informed consent on screening, comply with study requirements and procedures, and comply with clinic policies
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Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, and undergo hepatitis screening
EXCLUSION CRITERIA:
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Pregnant and/or breastfeeding females.
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Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Medstar Health Research Institute
Investigators
- Principal Investigator: Susan Moir, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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-β1 production and FcRL4 expression. Nat Immunol. 2013 Dec;14(12):1256-65. doi: 10.1038/ni.2746. Epub 2013 Oct 27.
- 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.
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- 91-I-0140