The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Conditions
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HIV

Intervention / Treatment
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* Procedure: Lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV negative<br> | Procedure: Lymph node biopsy<br>* Inguinal lymph node biopsy<br>|
| HIV positive<br> | Procedure: Lymph node biopsy<br>* Inguinal lymph node biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV persistence |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV persistence, Lymph node fibrosis