Recruiting

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

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Study Aim

This 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

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

From 18 to 100 Years
+16 Eligibility Criteria
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.More contacts
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 26, 1992

Actual date on which the first participant was enrolled.

We are studying the pathogenesis of HIV infection and other immune dysfunctions. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood and lymphoid tissues cells for studying aspects of either in vivo or in vitro HIV infection. A dichotomy exists between the amount of HIV that can be measured in peripheral blood compared to lymphoid tissue, as well as the types of immune cells that reside in each compartment. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection and other immune dysfunctions using human peripheral blood mononuclear cells and intact tissue or cells obtained from two major lymphoid organs, lymph nodes and bone marrow.

NCT00001316
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactCatherine A Seamon, R.N.More contacts
Last updated: July 23, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsAcquired Immunodeficiency Syndrome

Criteria

10 inclusion criteria required to participate
Ability to give informed, written consent

Absolute neutrophil count of greater than 1000/mm3

Adequate blood counts (PLWH: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; participants without HIV: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, platelets greater than or equal to 150,000)

Aged 18 years or older

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6 exclusion criteria prevent from participating
Any medical condition for which the PI feels LN BX might be contraindicated

Currently abusing alcohol or other drugs, including narcotics or cocaine

No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time

Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded

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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

Study Objectives

Primary Objectives

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 Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center