The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

This study is currently recruiting participants.
Verified October 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01202305
First received: September 9, 2010
Last updated: October 14, 2013
Last verified: October 2013

September 9, 2010
October 14, 2013
April 2011
April 2016   (final data collection date for primary outcome measure)
HIV persistence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01202305 on ClinicalTrials.gov Archive Site
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The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

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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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

Inguinal LN

Non-Probability Sample

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.

HIV
Procedure: Lymph node biopsy
Inguinal lymph node biopsy
  • HIV negative
    Intervention: Procedure: Lymph node biopsy
  • HIV positive
    Intervention: Procedure: Lymph node biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu
Contact: Marian Kerbleski, RN 415-476-4082 ext 144 KerbleskiM@php.ucsf.edu
United States
 
NCT01202305
10-03606
No
University of California, San Francisco
University of California, San Francisco
National Institutes of Health (NIH)
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP