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NCT Number: NCT01202305

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.

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Key information

Conditions

HIV

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Marian Kerbleski, RN

CONTACT

[email protected]

415-476-4082 ext. 144

Steven Deeks, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lymph node biopsy

Procedure

Inguinal lymph node biopsy

Primary outcomes

HIV persistence

Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Hoh, RD

CONTACT

[email protected]

415-502-2453

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2011
Primary completion: 2030
Study completion: 2030
First posted: Sep 15, 2010
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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