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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00333892
Enrollment
220
Registered
2006-06-06
Start date
2003-08-31
Completion date
2008-12-31
Last updated
2012-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

primary HIV infection, chronic HIV infection

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.

Interventions

PROCEDUREleukapheresis

pack of cells as per protocol

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Canadian Immunodeficiency Research Collaborative
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026