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
  Purpose

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 Intervention
HIV
Procedure: Lymph node biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • HIV persistence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Inguinal LN


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV negative Procedure: Lymph node biopsy
Inguinal lymph node biopsy
HIV positive Procedure: Lymph node biopsy
Inguinal lymph node biopsy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01202305     History of Changes
Other Study ID Numbers: 10-03606
Study First Received: September 9, 2010
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014