The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:11/10/2018
Start Date:April 2011
End Date:April 2030
Contact:Hiroyu Hatano, MD
Email:hhatano@php.ucsf.edu
Phone:415-476-4082

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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.


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
We found this trial at
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1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
Principal Investigator: Hiroyu Hatano, MD
Phone: 415-476-4082
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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