RECRUITING

The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Quick Facts

Study Start:2011-04
Study Completion:2030-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01202305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to give informed consent
  2. 2. No contraindication to surgical procedures
  3. 3. Palpable inguinal adenopathy at study entry
  4. 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")
  1. 1. Known anemia (HIV+ males Hct\<34; females Hct\<32) or contraindication to donating blood
  2. 2. Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
  3. 3. Platelets \< 50,000/mm3
  4. 4. PTT \> 2x ULN
  5. 5. INR \> 1.5
  6. 6. Pregnant

Contacts and Locations

Study Contact

Marian Kerbleski, RN
CONTACT
415-476-4082
Marian.Kerbleski@ucsf.edu

Principal Investigator

Steven Deeks, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

San Francisco General Hospital
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Steven Deeks, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-04
Study Completion Date2030-04

Study Record Updates

Study Start Date2011-04
Study Completion Date2030-04

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • HIV persistence
  • Lymph node fibrosis

Additional Relevant MeSH Terms

  • HIV