CClinicalTrials.gg
CompletedNCT00333892Updated Jun 5, 2012

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

An observational study in Human Immunodeficiency Virus, sponsored by Canadian Immunodeficiency Research Collaborative. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-06-05.

Sponsored by Canadian Immunodeficiency Research Collaborative · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Human Immunodeficiency Virus

Keywords

  • primary HIV infection
  • chronic HIV infection
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 220 is close to the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Canadian Immunodeficiency Research Collaborative is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Pregnant women
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • Procedureleukapheresis

    pack of cells as per protocol

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00333892
Lead sponsor
Canadian Immunodeficiency Research Collaborative
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jun 6, 2006
Start date
Aug 2003
Completion
Dec 2008
Last update
Jun 5, 2012

Study contacts

Mario Ostrowski, MD
principal investigator · University of Toronto
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion