Epoetin Alfa for HIV-Associated Neuropathy Trial

Inclusion Criteria: * Subject is a male or female ≥ 18 years old. * Subject has documented HIV-1 infection. * Subject has stable use or no use of specific dideoxynucleoside reverse transcriptase inhibitors (ie. ddI, d4T, ddc) for ≥4 months prior to Visit 1. * Subject has painful HIV-associated sensory neuropathy (either DSP or ATN), as confirmed by a neurologist. * Subject has an average severity of neuropathic pain over the 2 week period between visit 2 and Visit 3 of ≥0.74 units measured with the Gracely pain intensity scale. * Subject (either male or female) agrees not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and use of contraception. * Subjects hemoglobin is less than 13.0g/dl but greater than or equal to 10.0g/dl. Exclusion Criteria: * Subject has any condition other than HIV infection or antiretroviral therapy that in the opinion of the site neurologist confounds the diagnosis of neuropathy. * Subject has received insulin or oral hypoglycemic products for treatment of diabetes mellitus £30 days from Visit 1. * Subject has a documented history of untreated vitamin B12 deficiency (serum B12 level less than 200 pg/mL) or less than 3 months of B12 supplementation (injection or intranasal B12) prior to screening. Use of a multivitamin is permissible. * Subject has hereditary neuropathy or compression-related neuropathies, i.e. spinal stenosis, that would preclude analysis of treatment response. * Subject has received treatment with any drug other than the dideoxynucleoside analogues that the site neurologist considers to have significantly contributed to the subject's neuropathy ≤30 days from Visit 1. * Subject has a history of any alcohol-related medical complications within 6 months of Visit 1 including, but not limited to, alcohol withdrawal seizures, hallucinosis, delirium tremens, or being in a detoxification program. * Subject has received neurotoxic chemotherapeutic agents £90 days from Visit 1. * Subject has received neuroregenerative agents £90 days from Visit 1. * Subject has myelopathy that would interfere with the evaluation of the subject. * Subject has uncontrolled hypertension (Systolic Bp\>160mmHg and/or Diastolic Bp \>100mmHg) * Subject has known hypersensitivity to mammalian cell-derived products or albumin. * Subject has a history of thrombotic events or epileptic seizures. * Subject has an active AIDS-defining opportunistic infection (OI) or OI-defining condition £30 days from Visit 1. * Subject has active major disease, both HIV-related and non-HIV-related including, but not limited to, cardiac disease, pulmonary, or hepatorenal, which in the opinion of the investigator might affect the study. * Subject is pregnant or breast-feeding. * Subject has any currently active malignancy, or a history of any previous malignancy with the exception of skin squamous cell carcinoma or basal cell carcinoma. * Subject has received any investigational agent(s) that is not FDA-approved or has participated in any interventional research study £30 days from Visit 1. * Subject is actively using recreational intravenous drugs, crack cocaine, or intranasal/smoked heroin or methamphetamine. * Subject has chronic renal failure defined for the purposes of this study as a creatinine \>1.5 x upper limit of normal (ULN). * Subject has hepatitis C and is on interferon/ribavirin therapy or interferon/ribavirin therapy is planned over the expected course of the study. * Subject has received epoetin alfa (Procrit) within 2 months prior to study entry. * Subject has HgbA1C \>6.5. * Subject has serum B12 ≤200 pg/mL. * Subject has hemoglobin \<11.0 g/dL. * Subject has INR \>1.4 or platelets \<50,000.