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Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00039689
First received: June 6, 2002
Last updated: November 25, 2014
Last verified: November 2014
  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
HIV

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Immunologic and Virologic Assessments [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: May 2002
Detailed Description:

HIV infection is known to cause profound and irreversible dysfunction of both innate and adaptive arms of the immune system. However, there is mounting evidence 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 antiretroviral therapy (ART) on maintenance of immune cell function, we wish to recruit drug-na(SqrRoot) ve HIVinfected patients who are either in early or chronic stage of infection. The study will require that patients undergo leukapheresis or research blood draw once before and several times after enrollment. Leukapheresis will be used in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating the effect of ART on persistent HIV reservoirs in CD4+ T cells of infected individuals, and delineating CD8+ T cell-mediated suppression of viral replication and normalization of immune function, and characterizing natural killer (NK) function relative to HIV disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis 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 leukapheresis procedures, but the protocol, by itself, is not an independent research study. Alternatively, whole blood draws will be used in cases where patients are unable to undergo leukapheresis. While this approach will limit extensive functional analyses, informative phenotypic and limited functional analyses can nonetheless be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Adult (18 years old or older) HIV-1-infected patient

Adequate venous access for apheresis or sufficient research blood collection

Positive HIV antibody immunoassay and a positive confirmatory HIV test as defined by current CDC criteria. Tests may be done in our clinic or by an outside provider. For individuals with suspected early infection; the following criteria may be used: a history of exposure to a known source of HIV-infected material or individual or clinical symptoms and signs consistent with acute HIV infection (such as fever, sore throat, malaise, maculopapular rash combined with one of the following: a positive HIV antibody immunoassay and confirmatory HIV test as defined by current CDC criteria); or a positive HIV antibody immunoassay, with negative confirmatory test that subsequently evolves to a positive result; or HIV RNA levels of > 2,000 copies/ml with a negative result from an HIV antibody immunoassay.

Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy.

Blood pressure less than 180/100; pulse rate between 50-100 unless a lower pulse reat is considered normal for the volunteer

Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000)

Willingness to give informed consent including consent for the storage of blood samples and HLA testing

Antiretroviral naive or no antiretroviral use in the last six months

EXCLUSION CRITERIA:

Pregnant and/or breastfeeding women.

Be currently acusing alcohol or other drugs that potentially could interfere with patient compliance

Have a condition in the opinion of the investigators would make the patient ineligible for the study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039689

Contacts
Contact: Kathleen R Gittens (301) 496-9320 gittenskr@mail.nih.gov
Contact: Susan Moir, Ph.D. (301) 402-4559 sm221a@nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Moir, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00039689     History of Changes
Other Study ID Numbers: 020202, 02-I-0202
Study First Received: June 6, 2002
Last Updated: November 25, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Primary HIV Infection
Chronic HIV Infection
Antiretroviral Therapy
Innate Immunity
B Cell
HIV Infection
Acute Infection
Treatment Naive

ClinicalTrials.gov processed this record on November 25, 2014