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The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by University of California, San Francisco.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202305
First Posted: September 15, 2010
Last Update Posted: June 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco
September 9, 2010
September 15, 2010
June 30, 2015
April 2011
April 2017   (Final data collection date for primary outcome measure)
HIV persistence [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01202305 on ClinicalTrials.gov Archive Site
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Not Provided
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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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
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.
 
Unknown status
50
April 2017
April 2017   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01202305
10-03606
No
Not Provided
Not Provided
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
June 2015