NCT01202305 The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
| NCT ID | NCT01202305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | HIV |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2011-04 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2011-04 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Steven Deeks, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT01202305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01202305 currently recruiting?
Yes, NCT01202305 is actively recruiting participants. Contact the research team at Rebecca.Hoh@ucsf.edu for enrollment information.
Where is the NCT01202305 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT01202305 clinical trial?
NCT01202305 is sponsored by University of California, San Francisco. The principal investigator is Steven Deeks, MD at University of California, San Francisco. The trial plans to enroll 50 participants.
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