NCT00001316

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

Recruiting now Last updated 14 April 2026

What this trial tests

trial in HIV in 400 participants. Currently enrolling.

Timeline

26 August 1992

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	400
Start date	26 August 1992
Sites	1 location across United States

Conditions studied

• HIV — all drugs for HIV →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 100, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Overexpression of T-bet in HIV infection is associated with accumulation of B cells outside germinal centers and poor affinity maturation.
   Austin JW, Buckner CM, Kardava L, Wang W, et al · · 2019 · cited 86× · PMID 31776286 · DOI 10.1126/scitranslmed.aax0904
2. A follicular regulatory Innate Lymphoid Cell population impairs interactions between germinal center Tfh and B cells.
   O'Connor MH, Muir R, Chakhtoura M, Fang M, et al · · 2021 · cited 22× · PMID 33980982 · DOI 10.1038/s42003-021-02079-0
3. Lost in Translation: Lack of CD4 Expression due to a Novel Genetic Defect.
   Lisco A, Ye P, Wong CS, Pei L, et al · · 2021 · cited 14× · PMID 33471124 · DOI 10.1093/infdis/jiab025
4. Germinal Center T follicular helper (GC-Tfh) cell impairment in chronic HIV infection involves c-Maf signaling.
   Chakhtoura M, Fang M, Cubas R, O'Connor MH, et al · · 2021 · cited 12× · PMID 34280251 · DOI 10.1371/journal.ppat.1009732
5. Helper T cell immunity in humans with inherited CD4 deficiency.
   Guérin A, Moncada-Vélez M, Jackson K, Ogishi M, et al · · 2024 · cited 11× · PMID 38557723 · DOI 10.1084/jem.20231044
6. Rapid Emergence of T Follicular Helper and Germinal Center B Cells Following Antiretroviral Therapy in Advanced HIV Disease.
   Wong CS, Buckner CM, Lage SL, Pei L, et al · · 2021 · cited 3× · PMID 34938286 · DOI 10.3389/fimmu.2021.752782