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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)



Cellular Immunity;
Chronic HIV Infection;
Antiretroviral Therapy;
Primary HIV Infection;
Humoral Immunity;
Natural History

Recruitment Keyword(s)

HIV Infection;
Acute Infection;
Treatment Naive



Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Adult (18 years old or older) HIV-1-infected patient

Adequate venous access for research blood collection.

Positive HIV antibody immunoassay and a positive confirmatory HIV test (as defined by current CDC criteria). Tests may be done in our clinic or by an outside provider. For individuals with suspected early infection; the following additional criteria may be used: HIV RNA levels of >2,000 copies/ml with a negative result from an HIV antibody immunoassay.

Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy.

Blood pressure < 180/100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer.

Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000).

Willingness to give informed consent including consent for the storage of blood samples and genetic testing.

Antiretroviral naive, no antiretroviral use in the last six months, or previously enrolled 02-I-0202 subjects on whom there are samples stored in the repository.

Subjects who become HIV-infected while taking antiretroviral therapy for pre-exposure prophylaxis (PrEP) will be eligible for enrollment as long as them meet diagnostic criteria for HIV positivity.

Subjects who enroll under another LIR apheresis protocol within the past three months and complete the apheresis within 4 weeks of starting antiretroviral therapy will also be eligible for enrollment.

Patients with limited (no more than 4 weeks before screening visit) recent use of antiretroviral therapy may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol.


Pregnant and/or breastfeeding women.

Be currently abusing alcohol or other drugs that potentially could interfere with patient compliance or safety.

Have a condition which in the opinion of the investigators would make the patient ineligible for the study.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Susan Moir, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6A02
10 Center Drive
Bethesda, Maryland 20892
(301) 402-4559

Kathleen R. Gittens
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 9N214B
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8003

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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