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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT00333892
First received: June 2, 2006
Last updated: June 4, 2012
Last verified: June 2012
History of Changes

June 2, 2006
June 4, 2012
August 2003
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Complete list of historical versions of study NCT00333892 on ClinicalTrials.gov Archive Site
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Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients
Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients.
Probability Sample
HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test.
Human Immunodeficiency Virus
Procedure: leukapheresis
pack of cells as per protocol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
December 2008
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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
Both
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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Canada
 
NCT00333892
8737
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Canadian Immunodeficiency Research Collaborative
Canadian Immunodeficiency Research Collaborative
National Institutes of Health (NIH)
Principal Investigator: Mario Ostrowski, MD University of Toronto
Canadian Immunodeficiency Research Collaborative
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP