The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV

Treatments: Procedure: Lymph node biopsy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01202305

10-03606

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

HIV negative

Treatment:

Procedure: Lymph node biopsy

HIV positive

Treatment:

Procedure: Lymph node biopsy