Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 2, 2006 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00333892 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients | ||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||
| Study Design ICMJE | 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 ICMJE | Human Immunodeficiency Virus | ||||
| Intervention ICMJE | Procedure: leukapheresis
pack of cells as per protocol |
||||
| Study Group/Cohort (s) | 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 220 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00333892 | ||||
| Other Study ID Numbers ICMJE | 8737 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Canadian Immunodeficiency Research Collaborative | ||||
| Study Sponsor ICMJE | Canadian Immunodeficiency Research Collaborative | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Canadian Immunodeficiency Research Collaborative | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||