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Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001281
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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:

  • 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 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.
  • 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
HIV Immunodeficiencies Infectious Diseases

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.

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Study Type : Observational
Estimated Enrollment : 2600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in HIV-Infected and HIV-Uninfected Volunteers
Actual Study Start Date : March 9, 1993

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV Infected Individuals
HIV infected Individuals
HIV Uninfected Individuals
HIV uninfected Individuals
Individuals with/without Immunodeficiencies
Individuals with/without immunodeficiencies
Individuals with/without infectious diseases
Individuals with/without infectious diseases of interest



Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV-uninfected, HIV-infected volunteers, Volunteers with/without immunodeficiencies, Volunteers with/without infectious diseases of interest
Criteria
  • 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 (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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001281


Contacts
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Contact: Catherine A Seamon, R.N. (301) 402-3481 cseamon@cc.nih.gov
Contact: Susan Moir, Ph.D. (301) 402-4559 sm221a@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Medstar Health Research Institute
Investigators
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Principal Investigator: Susan Moir, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001281    
Other Study ID Numbers: 910140
91-I-0140
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: April 19, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .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.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Lymphocytes
Venipuncture
Mononuclear Cells
Natural History
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Disease Attributes
Pathologic Processes