View Clinical Trial (Medical Research Study)
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94110 |
| Conditions: |
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HIV |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01202305 |
| Primary Contact: |
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Principal Investigator
Hiroyu Hatano, MD
University of California, San Francisco
Hiroyu Hatano, MD
Phone: 415-476-4082 ext. 122
Email: hhatano@php.ucsf.edu
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| Backup Contact: |
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Email: KerbleskiM@php.ucsf.edu
Marian Kerbleski, RN
Phone: 415-476-4082 ext. 144
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| Location Contact: |
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San Francisco, California 94110
United States
Hiroyu Hatano, MD
Phone: 415-476-4082
Email: hhatano@php.ucsf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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