Lymph Node Biopsy for HIV/AIDS

Overseen By Rebecca Hoh, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Anemia, Blood coagulation disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how HIV lingers in the body by studying lymph nodes, small bean-shaped structures that help fight infection. Researchers will perform a lymph node biopsy, a minor surgical procedure to remove lymph nodes from the groin area, to assess the presence of HIV and the extent of any damage. The trial includes both HIV-positive and HIV-negative participants to compare results. Individuals with easily felt swollen lymph nodes in the groin area who can safely undergo a minor surgical procedure might be suitable for this study. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to new insights into HIV persistence.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, if you are on stable HIV treatment, you may need to continue it as part of the study.

What prior data suggests that this lymph node biopsy is safe?

Research has shown that lymph node biopsies are generally safe and well-tolerated when performed carefully. One study found that this procedure is practical and carries no major risks if done with care. Another study found that biopsies in the groin area are safe for most people, including those with early HIV infection. These findings suggest that a lymph node biopsy is a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses lymph node biopsies to explore how HIV affects the body at a deeper level. Unlike standard treatments that focus on managing the virus in the bloodstream, this approach aims to provide insights into its impact on the immune system directly. By examining lymph nodes, researchers hope to uncover new information about HIV pathogenesis, which could lead to innovative therapies in the future. This method could open up new paths in understanding the virus's behavior, ultimately improving treatment strategies.

What evidence suggests that this lymph node biopsy is effective for understanding HIV?

Research has shown that HIV can remain in the lymph nodes even when individuals take HIV medication for extended periods. This trial involves taking a small sample from the lymph nodes, called a biopsy, to determine the amount of HIV present. By examining the HIV genetic material in the lymph nodes, doctors can assess the extent of damage and the immune system's response to treatment. Understanding the amount of HIV in the lymph nodes helps predict how well CD4+ T cells, crucial for the immune system, might recover with treatment. This information aids doctors in creating better treatment plans and managing the long-term health of people with HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Deeks, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to give informed consent

No contraindication to surgical procedures

Palpable inguinal adenopathy at study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymph Node Biopsy

Lymph nodes from the groin area will be removed to assess HIV presence and lymph node damage

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lymph node biopsy

How Is the Trial Designed?

Group I: HIV positive Experimental Treatment 1 Intervention

Group II: HIV negative Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9441850/

Imaging and biopsy of HIV-infected individuals undergoing ... Initial data analysis will entail measurement of total HIV RNA by polymerase chain reaction (PCR) from lymph node biopsy specimens. Comparisons will be made ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT01202305

Lymph Node Biopsies to Support HIV Pathogenesis Studies The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies. a study on HIV/AIDS. Summary. Eligibility: for people ages 18 ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1258/td.2010.100145

Biopsy of peripheral lymph nodes: a useful tool to diagnose ... Peripheral lymph node biopsy is a simple and useful tool to diagnose opportunistic diseases in HIV-infected patients. Introduction. Lymph nodes ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213294518302308

Ultrasound-guided Fine Needle Aspiration Biopsy (USFNB ... HIV can persist in lymph nodes (LN) even for patients on long term antiretroviral therapy (ART). FNB allows for minimally invasive access to LNs.

5. haematologica.org haematologica.org/article/view/5799

Highly active antiretroviral therapy alone may be an ... We describe 4 cases of biopsy-proven HIV-associated MCD who showed a complete clinical and radiological response to MCD, and a reduction in KSHV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11385604/

Safety and practicality of an excisional lymph node study ... Our study demonstrates that when done with outmost care, obtaining excised lymph nodes for research is relatively safe and practical.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6143219/

Safety and Tolerability of Inguinal Lymph Node Biopsy in ... Conclusions: Inguinal LN biopsies were safe and well tolerated in mostly Thai men with AHI. As LN biopsies become an integral part of HIV research, this study ...

8. bmcresnotes.biomedcentral.com bmcresnotes.biomedcentral.com/articles/10.1186/s13104-019-4600-x

Safety and tolerance of lymph node biopsies from chronic HIV ... This is the first study to show that lymph node biopsy is a safe procedure and can be undertaken with local experts in rural settings.

9. ajronline.org ajronline.org/doi/10.2214/AJR.19.22334

HIV Lymphadenopathy: Differential Diagnosis and Important ... The purpose of this article is to review important imaging and clinical features to help elucidate causes of lymphadenopathy in patients with HIV infection.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2055664025000172

Dynamic changes in immune cell subsets in blood and ... HIV can be detected in peripheral lymph nodes in S1 and reaches peak levels as early as S2 of AHI. Data available in these early stages of infection have been ...