Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT01202305

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Lymph node biopsy

Study Details

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.

Conditions

HIV

Study ID

NCT01202305

Start date

Apr, 2011

Status verified date

Apr, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

HIV negative

HIV positive

Interventions

Lymph node biopsy

Inguinal lymph node biopsy

Primary outcome measure

  • HIV persistence [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rebecca Hoh, RD

415-502-2453Rebecca.Hoh@ucsf.edu

Locations

San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Marian Kerbleski, RN

415-476-4082Marian.Kerbleski@ucsf.edu

Principal Investigator:

Steven Deeks, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • HIV
  • HIV persistence
  • Lymph node fibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-01.