RecruitingNCT00039689

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

750 participants

Start Date

Jul 12, 2002

Study Type

OBSERVATIONAL

Conditions

Summary

There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease. Study participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study. Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours. This longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood and immune cells from HIV-positive adults who have never been on HIV treatment (antiretroviral-naïve) to study how the immune system responds to HIV in the early stages of infection. **You may be eligible if...** - You are 18 years of age or older - You are HIV-positive and have never taken antiretroviral (HIV) medication, or have not taken it in the last 6 months - You are willing to return for at least one follow-up visit within 4 months - Your blood pressure and blood counts are within acceptable ranges **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are currently misusing alcohol or drugs in a way that could affect your ability to participate safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00039689


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