The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

HIV medicines have led to dramatic improvements in health. However, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition, research has found that health is not completely restored in HIV-infected patients, even if they have been taking effective HIV medicines for a long time. This may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. Therefore, a more complete understanding of how HIV stays in the body is necessary.

Recent research has shown that one of the places that HIV can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines for a long time). In addition, the amount of damage to the lymphatic tissues can predict how the immune system (CD4+ T cell count) will respond to therapy.

The investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Procedure: Lymph node biopsy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Marian Kerbleski, RN; Phone Number: 144 415-476-4082; Email: Marian.Kerbleski@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • San Francisco General Hospital
      • Contact: Marian Kerbleski, RN; Phone Number: 144 415-476-4082; Email: Marian.Kerbleski@ucsf.edu
      • Principal Investigator: Steven Deeks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We propose a study in which inguinal lymph node biopsies will be performed on HIV-infected and uninfected subjects, with the goals of: 1) quantifying and characterizing residual virus in lymph nodes and 2) quantifying and comparing lymph node architecture in untreated subjects, HAART-suppressed subjects, elite controllers, and HIV-negative subjects. This research study will permit a lymph node biopsy to be performed and peripheral blood to be obtained from patients with HIV disease. Subjects with HIV or without HIV infection who have no contraindications to lymph node biopsy will be invited to participate in this study.

Description

Inclusion Criteria:

1. Able to give informed consent
2. No contraindication to surgical procedures
3. Palpable inguinal adenopathy at study entry
4. For HIV seropositive subjects, meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (HAART) with a recent undetectable viral load (< 50 copies/mL) ("HAART suppressed"), (2) antiretroviral untreated with an undetectable viral load (< 50 copies/mL) ("elite" controllers), or (3) antiretroviral untreated with a detectable viral load (> 1000 copies/mL) ("non-controllers")

Exclusion Criteria:

1. Known anemia (HIV+ males Hct<34; females Hct<32) or contraindication to donating blood
2. Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
3. Platelets < 50,000/mm3
4. PTT > 2x ULN
5. INR > 1.5
6. Pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV negative	Procedure: Lymph node biopsy; Inguinal lymph node biopsy
HIV positive	Procedure: Lymph node biopsy; Inguinal lymph node biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV persistence	1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Steven Deeks, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimated): September 15, 2010

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HIV; HIV persistence; Lymph node fibrosis
• Other Study ID Numbers: 10-03606