Examining HIV's impact on blood and lymph tissues
A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in People Living With HIV
This study looks at how HIV affects lymph nodes and blood in people with the virus compared to those without it, to better understand the damage it causes to the immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00001316 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of HIV on lymphoid tissues, particularly lymph nodes, compared to peripheral blood. It aims to understand how HIV accumulates and replicates in these tissues, contributing to immune system destruction. The study will analyze both the virus and the immune cells, specifically lymphocytes, from individuals living with HIV and compare them to control participants without HIV. Additionally, the research may involve using lymph node tissue and blood cells to develop new T-cells in the laboratory.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who are living with HIV and can provide informed consent.
Not a fit: Patients who are not living with HIV may not receive direct benefits from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of HIV pathogenesis and lead to improved treatments for individuals living with HIV.
How similar studies have performed: Previous studies have shown significant insights into HIV pathogenesis using similar methodologies, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:
1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.
2. Aged 18 years or older.
3. Ability to give informed, written consent.
4. The following laboratory values:
1. Absolute neutrophil count of greater than 1000/mm3.
2. PT, PTT within normal limits (unless PTT is elevated in presence of positive lupus anticoagulant in a participant with no prior history of abnormal bleeding).
3. Adequate blood counts (PLWH: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; participants without HIV: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, platelets greater than or equal to 150,000).
4. Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the participant.
5. Participants who do not have HIV will qualify as control participants.
6. Participants must have a clinically palpable lymph node in an easily accessible location.
7. Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening
EXCLUSION CRITERIA:
1. Women who are pregnant and/or breast-feeding.
2. Currently abusing alcohol or other drugs, including narcotics or cocaine.
3. Participants with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.
4. No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.
5. Any medical condition for which the PI feels LN BX might be contraindicated.
6. Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Susan L Moir, Ph.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Catherine A Seamon, R.N.
- Email: cseamon@cc.nih.gov
- Phone: (301) 402-3481
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.