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Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients

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ClinicalTrials.gov Identifier: NCT00333892
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative

Brief Summary:
To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Procedure: leukapheresis

Detailed Description:
Primary HIV-1 infected and chronically infected individuals will be recruited and leukapheresis will be performed. This one year study requires that patients be apheresed once before initiating therapy and on two other occasions (at month 6 and month 12) after suppression of plasma viremia. Peripheral blood mononuclear cells will be isolated by sodium diatrizoate density centrifugation and subjected to immunologic and virologic studies.

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients
Study Start Date : August 2003
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Procedure: leukapheresis
    pack of cells as per protocol


Biospecimen Retention:   Samples With DNA
Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test.
Criteria

Inclusion Criteria:

  • Adult 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 > 10,000 copies/mL by either RT-PCR or bDNA
  • Chronic HIV-infected patients should have a positive ELISA and a confirmatory western blot and willingness to give informed consent for the storage of blood.
  • Willingness to be able to make follow-up visits for apheresis at 6 and 12 months for those who undergo antiretroviral therapy

Exclusion Criteria:

  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333892


Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
National Institutes of Health (NIH)
Investigators
Principal Investigator: Mario Ostrowski, MD University of Toronto

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00333892     History of Changes
Other Study ID Numbers: 8737
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Canadian Immunodeficiency Research Collaborative:
primary HIV infection
chronic HIV infection

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases