Actively Recruiting

Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT00001316

Viral Load in Blood and Lymph Tissues in People Living With HIV

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-05

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study to determine the effect of the human immunodeficiency virus (HIV) on lymphoid tissues (e.g., lymph nodes) as compared to peripheral white blood cells. We have shown in previous studies that the lymph node is a major site of accumulation of HIV in the body, as well as being a site where much of the viral replication occurs which leads to the destruction of the body's immune system. To better understand the role of the lymph node in HIV infection and destruction of one s immunity, we wish to examine both the virus itself as well as the effects it is having on various types of white cells (called lymphocytes) obtained simultaneously from both peripheral blood and lymph nodes of people living with HIV (PLWH). We also need to look at cells derived from blood and lymph nodes from people who do not have HIV to serve as a control for experiments. We may also use your lymph node tissue and blood cells to attempt to make new T-cells, or rebuild the immune cells, in the laboratory by adding various factors or other substances released by different cells in the body. If you are living with HIV, you may be asked to undergo a second biopsy six weeks to 12 months after the first biopsy. Because of the ability of aspirin to interfere with blood clotting, you must have refrained from the use of aspirin for one week (7 days) prior to the biopsy date. You also cannot use non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g., ibuprofen, naproxen, and similar drugs) one week (7 days) prior to the biopsy. In addition, pregnancy testing will be performed on all females at the time of admission and a positive test will exclude you from participation. No participant will undergo more than six biopsies while participating in this study unless a particular research requires it.

CONDITIONS

Official Title

Viral Load in Blood and Lymph Tissues in People Living With HIV

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV status confirmed by licensed ELISA and Western blot or plasma viremia
  • Age 18 years or older
  • Ability to give informed, written consent
  • Absolute neutrophil count greater than 1000/mm3
  • PT and PTT within normal limits unless elevated PTT is due to positive lupus anticoagulant without bleeding history
  • Adequate blood counts: PLWH hemoglobin ≥9.0 g/dL, HCT ≥28%, platelets ≥75,000; controls hemoglobin ≥11.2 g/dL, HCT ≥34.1%, platelets ≥150,000
  • Blood pressure ≤180/100 and pulse rate 50-100 unless lower pulse is normal for participant
  • Controls must not have HIV
  • Clinically palpable lymph node in an easily accessible location
  • Willing to allow blood samples for future HIV studies, genetic testing, and hepatitis screening
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Current abuse of alcohol or other drugs including narcotics or cocaine
  • Diagnosis of AIDS dementia or AIDS-related malignancy other than minimal Kaposi's sarcoma
  • Use of aspirin or non-steroidal anti-inflammatory drugs within 7 days before biopsy (acetaminophen allowed)
  • Any medical condition making lymph node biopsy unsafe as judged by investigator
  • Planned sedation or use of narcotics (other than prescribed) or cocaine within 1 week before biopsy

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

C

Catherine A Seamon, R.N.

CONTACT

S

Susan L Moir, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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