Table 1.

Donor criteria for participation in the leukapheresis protocol.

Criterion	Acceptable Value
Participant Assessment / Interview
Ability to provide informed consent	Yes
Willing to receive HIV test results (if tested as part of entry into the study)	Yes
Ability and willingness to undergo the leukapheresis procedure for approximately 3 hours	Yes
Participant age	≥18 years (and ≤60 years if HIV-1 infected)
Participant weight	≥110 lbs (50 kg)
Appropriate venous access possible in both arms	Yes
Symptomatic of infection (including opportunistic infections if HIV-1 infected)	No
History of AIDS diagnosis	No
History of CD4 count <200 cell/μL in previous 6 months
History of autoimmune disease or other chronic disease (other than HIV-1 infection) for which leukapheresis would be contraindicated	No
Pregnancy	No
Ongoing bleeding disorder / hemorrhage or current anticoagulant therapy	No
History of malignancy (except squamous cell carcinoma) in previous 5 years	No
On an investigational drug	No
Pulse, blood pressure, and temperature at the time of screening and at the procedure	Within accepted normal limits for age / gender
Currently on angiotensin converting enzyme (ACE) inhibitor therapy	No
Participant Screening Laboratory Values
White blood count	>3.8 × 109 cells/L
CD4 count	≥300 cells/μL if HIV-1 infected, no criterion if HIV-1 negative
Hematocrit	≥35%
Platelet count	150 × 109 platelet/L
Albumin	≥3.5 g/dL
Ionized calcium	≥1.12 mmol/L