The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
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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 |
- 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 |
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.
Inclusion Criteria:
- Able to give informed consent
- No contraindication to surgical procedures
- Palpable inguinal adenopathy at study entry
- 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:
- Known anemia (HIV+ males Hct<34; females Hct<32) or contraindication to donating blood
- Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
- Platelets < 50,000/mm3
- PTT > 2x ULN
- INR > 1.5
- Pregnant
Contacts and Locations| 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, 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 | |
| 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 9, 2012 |
| 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 May 19, 2013