Clinical trial NCT00528593 (phase 2, status: withdrawn)
Conditions: hiv infections, neuropathy
ICD codes: Z21, G58.0, G61.1, A52.15, G60.3, G61.82, H46.2, H46.3
Drugs: epoetin alfa
SMILES: OC(=O)CNC(=O)C1C(=O)N(C2CCCCC2)C(=O)N(C2CCCCC2)C1=O
Reason stopped: 
    lack of pharmaceutical support
  
Eligibility criteria:

        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.