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Viral Burden Comparison in Blood and Lymphoid Tissue for People With HIV

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Study AimThis study aims to observe and compare the viral load and immune response in the blood and lymphoid tissues of people living with HIV.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

HIV

From 18 to 100 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: August 1992

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactCatherine A Seamon, R.N.
Last updated: September 22, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 26, 1992Actual date on which the first participant was enrolled.

This study is investigating how HIV affects different parts of the body, specifically comparing the virus's presence in the blood to its presence in lymphoid tissues such as lymph nodes and bone marrow. The focus is on people living with HIV to understand how the virus behaves in different areas and how it affects the immune system. The study is important because it could help improve how HIV is treated by revealing new insights into how the virus interacts with the body's immune cells, potentially leading to better therapies that target these interactions. Participants in the study will have samples taken from their blood and possibly from lymph nodes and bone marrow to measure the levels of HIV and observe immune system changes. The study aims to assess how treatments affect the virus's presence and immune activation in different tissues. Researchers will also examine the immune system's regulatory mechanisms and how the virus alters normal immune cell functions. This observational study is crucial for identifying differences in viral burden across body compartments, which could have significant implications for future HIV treatment strategies.

Official TitleA Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in People Living With HIV 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactCatherine A Seamon, R.N.
Last updated: September 22, 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
400 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 100 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
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
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Individuals with HIV
Group II
Individuals without HIV
Study Objectives
Primary Objectives

The purpose of this project is to determine the relative burden of human immunodeficiency virus (HIV) and/or associated changes in hematopoiesis and immune activation as well as HIV-specific responses in the various subsets of peripheral blood mononuclear cells versus the lymphoid tissues (LT) and bone marrow (BM) in people living with HIV (PLWH).

We wish to delineate the precise nature of the immunoregulatory mechanisms and altered homing patterns that contribute to the perturbations in the phenotype and functions of various lymphocyte subsets in peripheral blood versus the lymphoid tissues (LT) of people living with HIV (PLWH).

We wish to examine the effect of therapy on viral burden and/or immune activation in the immunoregulatory pathways observed in lymphocyte subsets in lmyphoid tissues (LT) versus peripheral blood mononuclear cells. For LT specimen, the analyses can be performed both on intact tissue sections and excised cells.

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 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
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One Study Center
Viral Burden Comparison in Blood and Lymphoid Tissue for People With HIV | PatLynk