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Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients Clinical research trials and Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients. Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients clinical trial. Subjects often receive the most expert healthcare possible for their Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients  Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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. 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
Total Enrollment: 90
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020202; 02-I-0202
Study Start Date: May 20, 2002
Record last reviewed: April 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039689
Other Hiv Infections Studies:
1. Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome
2. The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
3. Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
4. A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
5. Tuberculosis in HIV Infected Patients in Uganda
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients
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