Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection

Exclusion Criteria

• •Abnormal hematology at Screening 1: Absolute neutrophil count (ANC) \< 1.5 x 109/L, Platelet count \< 100 x 109/L, Hemoglobin \< 10 g/dL
• •Abnormal biochemistry at Screening 1: Alanine aminotransferase (ALT) \> 2.5 x Upper Limit of Normal (ULN), Total bilirubin \> 1.5 x ULN, Serum creatinine \> 1.5 x ULN
• •Detection of any CXCR4-tropic HIV-1 at Screening 1
• •Evidence of co-infection with hepatitis B virus, hepatitis C virus, West Nile Virus, or HTLV-1 as detected at Screening 2
• •Evidence of active TB infection determined by positive QuantiFERON®-TB Gold/IGRA test result and clinical confirmation at Screening 2
• •ART or other antiretroviral therapy within 6 weeks of Screening 1 or any time during the pre-infusion period
• •Documented history of CD4+ T lymphocyte count \< 250 cells/µl
• •Any previous or current AIDS-defining illnesses (CDC Category C), including AIDS-related dementia, with the exception of Kaposi's sarcoma confined to the skin
• •History of malignancy or systemic chemotherapy within the last 5 years (i.e., subjects with prior malignancy must be disease-free for 5 years), except curatively-treated basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical or anal intra-epithelial neoplasia
• •History of steroid-dependent asthma in the past 5 years
• •History of seizure
• •Any clinical history of hematologic diseases including leukemia, myelodysplasia, myeloproliferative disease, thromboembolic disease, sickle cell disorder, thrombocytopenia or leukopenia
• •Class II-IV heart failure, according to the New York Heart Association classification
• •Inadequate venous access for apheresis, as assessed at Screening 1
• •Current or planned systemic immunosuppressive or immunomodulatory medication
• •Taking warfarin, aspirin or any medication that is likely to affect platelet function or other aspects of blood coagulation, and unable to safely cease this medication for a period of 1 week prior, during, and 1 week after administration of G-CSF (a total period of 19 days)
• •Participation in any study involving any investigational drug or medical device within 30 days prior to Screening 1
• •Receipt of a vaccine for HIV-1 or any gene transfer product at any time
• •Prior treatment with recombinant G-CSF or busulfan or other stem-cell mobilizing or modulating agent within the previous 12 months
• •Known hypersensitivity to busulfan, G-CSF (Neupogen™) or E. coli-derived proteins
• •Subjects who will not accept transfusions of blood products
• •Pregnant or breast-feeding at any time between Screening 1 and Baseline (infusion)
• •History of alcohol or drug abuse within the 12 months prior to Screening 1
• •Inability to understand and provide informed consent