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
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Sponsor:
Canadian Immunodeficiency Research Collaborative
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
Tracking Information | ||||
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First Submitted Date | June 2, 2006 | |||
First Posted Date | June 6, 2006 | |||
Last Update Posted Date | June 5, 2012 | |||
Study Start Date | August 2003 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00333892 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients | |||
Official Title | Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients | |||
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. | |||
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 | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients. |
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Sampling Method | Probability Sample | |||
Study Population | HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test. | |||
Condition | Human Immunodeficiency Virus | |||
Intervention | Procedure: leukapheresis
pack of cells as per protocol |
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Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
220 | |||
Original Enrollment |
60 | |||
Actual Study Completion Date | December 2008 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number | NCT00333892 | |||
Other Study ID Numbers | 8737 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Canadian Immunodeficiency Research Collaborative | |||
Study Sponsor | Canadian Immunodeficiency Research Collaborative | |||
Collaborators | National Institutes of Health (NIH) | |||
Investigators |
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PRS Account | Canadian Immunodeficiency Research Collaborative | |||
Verification Date | June 2012 |