NIH Clinical Research Studies

Protocol Number: 02-I-0202

Active Accrual, Protocols Recruiting New Patients

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:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Active Accrual Of New Subjects
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.

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 women

Special Instructions: Currently Not Provided
Keywords:
Primary HIV Infection
Chronic HIV Infection
Soluble Factors
Antiretroviral Therapy
Innate Immunity
B Cells
CD8+ T Cell
Recruitment Keywords:
HIV Infection
Acute Infection
Treatment Naive
Conditions:
HIV Infections
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
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

Citations:
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 PMID: 8057491

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 PMID: 8638160

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 PMID: 10737796

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/26/2004

Search The Studies Help Questions