The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Recruiting

• Conditions: HIV
• Interventions: Procedure: Lymph node biopsy

• Registration Number: NCT01202305
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Study Start: 2011-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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")

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV negative	Lymph node biopsy	-
HIV positive	Lymph node biopsy	-

Primary Outcome Measures

Name	Time	Method
HIV persistence	1 year

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States