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

Tracking Information
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
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients.
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
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: June 4, 2012)	220
Original Enrollment; (submitted: June 2, 2006)	60
Actual Study Completion Date	December 2008
Primary Completion Date	Not Provided
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Mario Ostrowski, MD University of Toronto
PRS Account	Canadian Immunodeficiency Research Collaborative
Verification Date	June 2012