Epoetin Alfa for HIV-Associated Neuropathy Trial

• Status: Withdrawn
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Ortho Biotech Clinical Affairs, L.L.C.; PPD
• Treatments: Epoetin Alfa

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.