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The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

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ClinicalTrials.gov Identifier: NCT01202305
Recruitment Status : Unknown
Verified June 2015 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : September 15, 2010
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
HIV Procedure: Lymph node biopsy

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
Study Start Date : April 2011
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
HIV negative Procedure: Lymph node biopsy
Inguinal lymph node biopsy
HIV positive Procedure: Lymph node biopsy
Inguinal lymph node biopsy


Outcome Measures

Primary Outcome Measures :
  1. HIV persistence [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Inguinal LN

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202305


Contacts
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

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
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   
Principal Investigator: Hiroyu Hatano, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Investigators
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01202305     History of Changes
Other Study ID Numbers: 10-03606
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by University of California, San Francisco:
HIV
HIV persistence
Lymph node fibrosis