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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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