Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT00029445
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Study Details
This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients. People living with HIV who are 18 years of age and older, documented or suspected long-term nonprogressors in generally good health may be eligible to screen for the study. Participants will undergo apheresis (a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw) if venous access is adequate once yearly. Some may be asked to return every six months. * Automated apheresis - Blood is drawn through a needle placed in an arm vein and spun in a machine, separating the blood components. The white cells are extracted and the red cells, with or without plasma (liquid part of the blood), are re-infused into the donor through a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing. * Blood draw - a needle placed in an arm vein for large volume (approx 75ml) blood draw if veins considered inadequate for apheresis procedure. Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system.
Key Dates
- Start date
- Aug 9, 2001
- Status verified
- Jun 2026
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Family membersFamily members of individuals with innate control over HIV
- Arm: HIV infection with one of the following HLA types: B*27+, B*35+,B*44+, B*57+, B*58+, and/or A*02.People living with HIV with specific HLA-types.
- Arm: Long term nonprogressorsIndividuals with innate control over HIV
Primary Outcome Measure
To further investigate differences in the virus-specific T cell-mediated responses between HIV-1-infected LTNP and patients with progressive disease who bear HLA class I alleles that have been associated with delayed disease progression and to c... [ Time Frame: Ongoing ]
Central Contacts
- Rosemary McConnell, R.N.(301) 312-1235
- Daniel C Rogan, M.D.(301) 642-3852
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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