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NCT01202305Recruiting

The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
9 Sept 2010
Start date
Apr 2011
Primary completion date
Apr 2030
Lead sponsor
University of California, San Francisco
Diseases
HIV
NCT number
NCT01202305

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From Apr 2011 to the primary completion date, Apr 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Lab values

  • Platelets \< 50,000/mm3
  • PTT \> 2x ULN
  • INR \> 1.5

Other

  • Pregnant

Who the study is looking for

  • 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")

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Francisco General Hospital
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.