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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00039689 |
Purpose
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 |
|---|
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HIV Infections |
| Study Type: | Observational |
| Official Title: | Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-Infected Patients |
| Estimated Enrollment: | 270 |
| Study Start Date: | May 2002 |
HIV-1 infection is known to cause profound and irreversible dysfunction of both innate and adaptive arms of the immune system. However, there is mounting evident that early and aggressive treatment with antiretroviral drugs can prevent loss of immune cell function. In an attempt to further delineate the effect of early highly active antiretroviral therapy (HAART) on maintenance of immune cell function, we wish to recruit drug-naive HIV-infected patients who are either at the acute or chronic stage of infection and who have elected to begin HAART. The study will require that patients be apheresed once before and several times after suppression of plasma viremia. Apheresis will be necessary in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating CD8 factors associated with suppression of viral replication and normalization of immune function, and characterizing natural killer function relative to HIV disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis procedures, but the protocol, by itself, is not an independent research study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 020202, 02-I-0202 |
| Study First Received: | June 6, 2002 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039689 History of Changes |
| Health Authority: | United States: Federal Government |
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Primary HIV Infection Chronic HIV Infection Soluble Factors Antiretroviral Therapy Innate Immunity |
B Cells CD8+ T Cell HIV Infection Acute Infection Treatment Naive |
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Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
