Recruiting

HIV Pathogenesis in Human Blood and Body Fluids

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Study AimThis study aims to observe and collect blood and other biological samples from individuals for research on HIV and other infectious or immune deficiency diseases.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

HIV

+ Immunodeficiencies
+ Infectious Diseases
From 18 to 120 Years

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 1993

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactCatherine A Seamon, R.N.
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 9, 1993Actual date on which the first participant was enrolled.

This study aims to understand more about how HIV affects the body by examining blood and other body fluids from people living with and without HIV. Researchers are interested in the biological processes and immune system responses in individuals with HIV and other immune system disorders. Since there isn't a suitable animal model to study HIV effectively, scientists rely on human blood cells to explore how the virus operates and impacts the immune system. This research is important as it might help improve treatments and understanding of HIV and similar immune-related conditions. Participants in this study will provide blood and possibly other biological samples. The study is observational, meaning it focuses on collecting and analyzing samples rather than testing new treatments. Researchers will evaluate various biological factors to see how HIV and other immune diseases affect the body. There are no direct risks or benefits mentioned for participants, as the study's main goal is to gather information that could potentially lead to better understanding and management of these diseases in the future.

Official TitleStudies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactCatherine A Seamon, R.N.
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2419 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV
Immunodeficiencies
Infectious Diseases
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Individuals living with/without HIV
Group II
Individuals living with/without infectious diseases of interest
Group III
Individuals with/without immunodeficiencies
Study Objectives
Primary Objectives

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 Objectives

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
Completed
Washington Hospital CenterWashington D.C., United States
Recruiting
2 Study Centers