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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333892
First Posted: June 6, 2006
Last Update Posted: June 5, 2012
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
  Purpose
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.

Condition Intervention Phase
Human Immunodeficiency Virus Procedure: leukapheresis Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Biospecimen Retention:   Samples With DNA
Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients.

Enrollment: 220
Study Start Date: August 2003
Study Completion Date: December 2008
Intervention Details:
    Procedure: leukapheresis
    pack of cells as per protocol
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333892


Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
National Institutes of Health (NIH)
Investigators
Principal Investigator: Mario Ostrowski, MD University of Toronto
  More Information

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00333892     History of Changes
Other Study ID Numbers: 8737
First Submitted: June 2, 2006
First Posted: June 6, 2006
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Canadian Immunodeficiency Research Collaborative:
primary HIV infection
chronic HIV infection

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases


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