Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
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|ClinicalTrials.gov Identifier: NCT00039689|
Recruitment Status : Recruiting
First Posted : June 7, 2002
Last Update Posted : September 22, 2020
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease.
Study participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study.
Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours.
This longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-Infected Patients|
|Actual Study Start Date :||July 12, 2002|
HIV chronic infection
For example, an individual infected with HIV-1 for an indeterminate amount of time.
HIV early infection
For example, a negative HIV antibody immunoassay within 6 months of a positive HIV antibody assay and confirmatory test (as defined by current CDC criteria).
- To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients [ Time Frame: Throughout the study ]To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with early HIV infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039689
|Contact: Kathleen R Gittens||(301) email@example.com|
|Contact: Susan Moir, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Susan Moir, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|