ClinicalTrials.gg
RecruitingNCT00001281Updated Oct 29, 2026

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

An observational study in HIV, Immunodeficiencies and Infectious Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 2 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

From the registry’s dates

  • Started Mar 1993; still recruiting 33 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,419
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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....

Read the 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.

02

Conditions studied

  • HIV
  • Immunodeficiencies
  • Infectious Diseases

Keywords

  • Lymphocytes
  • Venipuncture
  • Mononuclear Cells
  • Natural History
03

In context

Immunologic Deficiency Syndromes

204 studies on the registry are indexed under Immunologic Deficiency Syndromes; 50 are open to participants now.

This study's planned enrollment of 2,419 is above the median of 181 across 72 observational studies indexed under Immunologic Deficiency Syndromes.

Browse Immunologic Deficiency Syndromes studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Volunteers living with/without HIV, Volunteers with/without immunodeficiencies, Volunteers with/without infectious diseases of interest

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 : greater than or equal to 9.0 g/dL, 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 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

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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,419 participants (estimated)

Groups and cohorts

  • Individuals living with/without HIV

    Individuals living with/without HIV

  • Individuals living with/without infectious diseases

    Individuals living with/without infectious diseases of interest

  • Individuals with/without Immunodeficiencies

    Individuals with/without immunodeficiencies

06

What researchers measure

Primary outcomes

  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

    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

Secondary outcomes

  1. 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

    Time frame: Throughout

07

Study locations

1 of 2 sites recruiting
  • Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    Completed

    Not enrolling at this site.

  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
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References and documents

Publications

  • 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. PubMed 24162774 ↗
  • 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. PubMed 24603698 ↗
  • 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. PubMed 22645343 ↗

Individual participant data

Plan to share: Yes — 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 information: 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.

09

Timeline

3 registry updates since Sep 25, 2026

Started Mar 1993 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Mar 9, 1993
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description
3 updates, last Oct 29, 2026
Show all 3 updates
  1. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 8, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001281
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Mar 9, 1993
Last update
Oct 29, 2026

Study contacts

Catherine A Seamon, R.N.
Contact
cseamon@cc.nih.gov
(301) 402-3481
Susan L Moir, Ph.D.
Contact
sm221a@nih.gov
(301) 402-4559
Susan L Moir, Ph.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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