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Protocol Number:
02-I-0202
- Title:
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-Infected Patients
- Number:
02-I-0202
- Summary:
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.
- Sponsoring Institute:
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National Institute of Allergy and Infectious Diseases (NIAID)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
INCLUSION CRITERIA:
Adult (18 years old or older) HIV-1-infected patient
For primary infected patients anyone with an exposure to a known source of HIV infected material or individual, with symptoms and signs if present consistent with primary HIV infection, a negative ELISA, indeterminate Western blot for HIV and a positive HIV plasma RNA levels greater than 10,000 copies/mL by either RT-PCR or bDNA as determined by tests done in our clinic or tests from patient's primary care provider within the last 4 months.
Chronic HIV-infected patients should have a positive ELISA and a confirmatory western blot and a positive HIV RNA in plasma by RT-PCR or bDNA as determined by tests done in our clinic.
Willingness to give informed consent for the storage of blood or tissue samples and HLA testing.
Willingness to give informed consent.
Willingness to be able to make follow up visits for apheresis at least once in the next 4 months for those who undergo antiretroviral therapy.
EXCLUSION CRITERIA:
Pregnant and/or breastfeeding women.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Primary HIV Infection
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Chronic HIV Infection
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Soluble Factors
-
Antiretroviral Therapy
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Innate Immunity
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B Cells
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CD8+ T Cell
- Recruitment Keyword(s):
-
HIV Infection
-
Acute Infection
-
Treatment Naive
- Condition(s):
-
HIV Infections
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Allergy and Infectious Diseases
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
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Borrow P, Lewicki H, Hahn BH, Shaw GM, Oldstone MB Virus-specific CD8+ cytotoxic T-lymphocyte activity associated with control ofviremia in primary human immunodeficiency virus type 1 infection J Virol 1994 Sep;68(9):6103-10
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Mellors JW, Rinaldo CR Jr, Gupta P, White RM, Todd JA, Kingsley LA Prognosis in HIV-1 infection predicted by the quantity of virus in plasma Science 1996 May 24;272(5265):1167-70
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Oxenius A, Early highly active antiretroviral therapy for acute HIV-1 infection preservesimmune function of CD8+ and CD4+ T lymphocytes Proc Natl Acad Sci U S A 2000 Mar 28;97(7):3382-7
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Bethesda, Maryland 20892. Last update: 01/13/2009
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