HIV Infections Clinical Trial
Official title:
A Randomized, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-associated Sensory Neuropathy
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | National Institute of Neurological Disorders and Stroke (NINDS), Ortho Biotech Clinical Affairs, L.L.C., PPD |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the distal leg intra-epidermal nerve fiber density | at baseline and after 48 weeks of treatment | Yes | |
Secondary | Change in pain levels measured via Gracely pain scale between baseline and every 6 weeks thereafter up to 48 weeks | up to 48 weeks | Yes | |
Secondary | Change in global physician impression from the Visit 4 baseline measurement and measurement after 48 weeks of treatment | baseline and after 48 weeks of treatment | Yes | |
Secondary | Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment | at baseline and after 48 weeks of treatment | Yes |
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