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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001281
• Other study ID #: 910140
• Secondary ID: 91-I-0140
• Status: Recruiting
• Start date: March 9, 1993

Study information

• Verified date: February 9, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Catherine A Seamon, R.N.
• Phone: (301) 402-3481
• Email: cseamon[@]cc.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV
• HIV Infections
• Immunodeficiencies
• Infections
• Infectious Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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

External Links

•   NIH Clinical Center Detailed Web Page