Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Primary and Chronic HIV-Infected Patients

HIV infection is known to cause profound and irreversible dysfunction of both innate and
adaptive arms of the immune system. However, there is mounting evidence that early and
aggressive treatment with antiretroviral drugs can prevent loss of immune cell function. In
an attempt to further delineate the effect of early antiretroviral therapy (ART) on
maintenance of immune cell function, we wish to recruit drug-na(SqrRoot) ve HIVinfected
patients who are either in early or chronic stage of infection. The study will require that
patients undergo leukapheresis or research blood draw once before and several times after
enrollment. Leukapheresis will be used in order to obtain sufficient cells to pursue the
following objectives: delineating B cell response to CD4+ T cell help, delineating the effect
of ART on persistent HIV reservoirs in CD4+ T cells of infected individuals, and delineating
CD8+ T cell-mediated suppression of viral replication and normalization of immune function,
and characterizing natural killer (NK) function relative to HIV disease. The required number
of mononuclear cells needed to perform these experiments can be easily and safely obtained
using leukapheresis procedures in the Clinical Center Apheresis Unit. This protocol is
specifically designed to conform to the requirements of the Apheresis Unit for donors to have
leukapheresis procedures, but the protocol, by itself, is not an independent research study.
Alternatively, whole blood draws may be used in cases where patients are unable to undergo
leukapheresis. While this approach will limit extensive functional analyses, informative
phenotypic and limited functional analyses can nonetheless be performed.

- INCLUSION CRITERIA:

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

Adequate venous access for apheresis or sufficient 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 less than 180/100; pulse rate between 50-100 unless a lower pulse reat 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 or 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 prior to starting antiretroviral therapy will also be

eligible for enrollment.

EXCLUSION CRITERIA:

Pregnant and/or breastfeeding women.

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

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