The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

NCT ID: NCT01202305

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2030-04-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HIV negative

Lymph node biopsy

Intervention Type: PROCEDURE

Inguinal lymph node biopsy

HIV positive

Lymph node biopsy

Intervention Type: PROCEDURE

Inguinal lymph node biopsy

Interventions

Lymph node biopsy

Inguinal lymph node biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Deeks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Hoh, RD

Role: CONTACT

Rebecca.Hoh@ucsf.edu

415-502-2453

Facility Contacts

Marian Kerbleski, RN

Role: primary

Marian.Kerbleski@ucsf.edu

415-476-4082 ext. 144

Other Identifiers

10-03606

Identifier Type: -

Identifier Source: org_study_id