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RPHI Study

Study Name

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naïve HIV-Infected Patients

Study Number

02-I-0202

Goal of Study

Determining how the immune system of some patients is able to control HIV is felt to be a very important step for designing vaccines and therapies for HIV. A certain number of patients who are treated with highly active antiretroviral therapy (HAART) early during HIV infection have been able to maintain their immunity against HIV, and in a subcategory of patients, early treatment allows patients to stop their medication while preventing their virus from returning to unsafe levels. Our laboratory is recruiting HIV-infected patients to further understand the mechanism(s) involved in maintenance of immune function following early intervention with antiretroviral therapy. In addition, for purposes of comparison, patients who have passed the early stage of HIV infection are also being recruited.

Study Regimen

The mechanism of immune system mediated control of HIV is being studied through the use of the blood products (white blood cells and plasma) of patients in a number of assays. These blood products will be removed by apheresis. In apheresis, blood is removed through a needle in the vein of one arm, spun in a machine which permits separation of the desired blood component (usually white blood cells and plasma), and then the remainder is re-infused either through the same needle or through a needle in a vein in the other arm. An anticoagulant (a medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during this processing.
The study will require that patients consent to leukapheresis at least once before they start or resume highly active antiretroviral therapy (HAART), and several times after suppression of the virus (when the viral load is less than 50 copies). The study does not provide HAART. Volunteers will be compensated.

Eligibility Criteria

  • You are age 18 and older, with documented HIV-infection.
  • You have never taken HIV medications, or you have been off HIV medications for at least six months.
  • You have adequate veins for blood draws and apheresis.
  • You consent to genetic testing, and allow the NIH to store your blood samples.
  • You are not pregnant.
  • You are not currently abusing alcohol or drugs.
Content last reviewed on November 29, 2016