The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

HIV Clinical Trial

Official title:

The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01202305
• Other study ID #: 10-03606
• Status: Recruiting
• Start date: April 2011
• Est. completion date: April 2030

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Marian Kerbleski, RN
• Phone: 415-476-4082
• Email: Marian.Kerbleski[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Procedure:
• Lymph node biopsy
Inguinal lymph node biopsy

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV persistence		1 year