Understanding HIV infection through blood cell studies
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
This study is testing how HIV affects the immune system by looking at blood samples from people living with the virus to better understand the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2419 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT00001281 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the virologic and immunologic parameters of HIV infection and other immune deficiency diseases using human peripheral blood cells. The research aims to elucidate the pathogenic aspects of HIV in relation to immune regulation and dysregulation. Participants will provide blood samples for analysis, which will help in understanding the disease's pathogenesis. The study is crucial due to the lack of adequate animal models for HIV research.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, both living with and without HIV, who meet specific health criteria.
Not a fit: Patients who are pregnant, breastfeeding, or have active substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to a better understanding of HIV pathogenesis, potentially informing new treatment strategies.
How similar studies have performed: Previous studies utilizing human blood cells for HIV research have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * 18 years of age or older. * Adequate venous access. * Have a blood pressure less than or equal to 180/100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer. * Have adequate blood counts (volunteers living with HIV: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000; volunteers living without HIV: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000 * Be willing and able to provide written informed consent on screening, comply with study requirements and procedures, and comply with clinic policies * Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, and undergo hepatitis screening EXCLUSION CRITERIA: * Pregnant and/or breastfeeding females. * Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise volunteer safety.
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Washington Hospital Center — Washington D.C., District of Columbia, United States (Completed)
- 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.