Using lymph node biopsies to study HIV persistence
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
University of California, San Francisco · NCT01202305
This study is trying to see how HIV stays in the body, especially in lymph nodes, even when people are on treatment, to better understand its effects on the immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT01202305 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how HIV persists in the body, particularly in lymphatic tissues such as lymph nodes, even in patients on effective antiretroviral therapy. By removing lymph nodes from the groin area of participants, researchers hope to gain insights into the damage caused by HIV and how it affects the immune system's response to treatment. The study will include HIV-positive individuals with varying treatment statuses and aims to correlate lymph node health with immune function.
Who should consider this trial
Good fit: Ideal candidates include HIV-positive individuals with palpable inguinal adenopathy who are either on stable antiretroviral therapy or are untreated with varying viral loads.
Not a fit: Patients who are pregnant or have significant blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of HIV persistence and inform more effective treatment strategies for patients.
How similar studies have performed: While the approach of studying lymph node biopsies in HIV research is not widely tested, similar studies have shown promise in understanding HIV pathogenesis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- San Francisco General Hospital — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Steven Deeks, MD — University of California, San Francisco
- Study coordinator: Rebecca Hoh, RD
- Email: Rebecca.Hoh@ucsf.edu
- Phone: 415-502-2453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV, HIV persistence, Lymph node fibrosis