Clinical trial NCT01202305: The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
Official title: The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
HIV persistence
Lymph node fibrosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We propose a study in which inguinal lymph node biopsies will be performed on HIV-infected and uninfected subjects, with the goals of: 1) quantifying and characterizing residual virus in lymph nodes and 2) quantifying and comparing lymph node architecture in untreated subjects, HAART-suppressed subjects, elite controllers, and HIV-negative subjects. This research study will permit a lymph node biopsy to be performed and peripheral blood to be obtained from patients with HIV disease. Subjects with HIV or without HIV infection who have no contraindications to lymph node biopsy will be invited to participate in this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: HIV persistence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steven Deeks, MD
role: PRINCIPAL_INVESTIGATOR
References: