Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00001281

Conditions

HIV

Immunodeficiencies

Infectious Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

HIV

Immunodeficiencies

Infectious Diseases

Study ID

NCT00001281

Start date

Mar 9, 1993

Status verified date

Aug 5, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

2419 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Catherine A Seamon, R.N.

(301) 402-3481cseamon@cc.nih.gov

Susan L Moir, Ph.D.

(301) 402-4559sm221a@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

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

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 8, 2026

Last verified

Aug 5, 2026

Keywords

  • Lymphocytes
  • Venipuncture
  • Mononuclear Cells
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-08.