The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

NCT01202305 | Recruiting

• 1 other identifier: 10-03606
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV; HIV persistence; Lymph node fibrosis

Outcome Measures

Primary Outcomes (1)

• HIV persistence

  1 year

Study Arms (2)

HIV negative

Procedure: Lymph node biopsy

HIV positive

Procedure: Lymph node biopsy

Interventions

Lymph node biopsy PROCEDURE

Inguinal lymph node biopsy

HIV negative; HIV positive

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Able to give informed consent
• No contraindication to surgical procedures
• Palpable inguinal adenopathy at study entry
• 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")

You may not qualify if:

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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Inguinal LN

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Steven Deeks, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Hoh, RD

CONTACT

415-502-2453; Rebecca.Hoh@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 15, 2010
• Study Start: April 1, 2011
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)