Epoetin Alfa for HIV-Associated Neuropathy Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00528593
• Date of registration: 11/09/2007
• Primary sponsor: Washington University School of Medicine
• Public title: Epoetin Alfa for HIV-Associated Neuropathy Trial
• Scientific 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
• Date of first enrolment: November 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00528593
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Pablo Tebas, MD
• Affiliation: Associate Professor of Medicine, University of Pennsylvania

• Name: Justin McArthur, MBBS, MPH
• Affiliation: Professor of Neurology, Johns Hopkins University

• Name: David Simpson, MD
• Affiliation: Professor of Neurology, Mt. Sinai Medical Center

• Name: Bruce Cohen, MD
• Affiliation: Professor of Neurology, Northwestern University

• Name: David B. Clifford, MD
• Affiliation: Professor of Neurology, Washington University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Neuropathy

Intervention(s)

Drug: epoetin alfa

Primary Outcome(s)

Difference between the distal leg intra-epidermal nerve fiber density [Time Frame: at baseline and after 48 weeks of treatment]

Secondary Outcome(s)

Change in global physician impression from the Visit 4 baseline measurement and measurement after 48 weeks of treatment [Time Frame: baseline and after 48 weeks of treatment]

Change in pain levels measured via Gracely pain scale between baseline and every 6 weeks thereafter up to 48 weeks [Time Frame: up to 48 weeks]

Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment [Time Frame: at baseline and after 48 weeks of treatment]

Secondary ID(s)

U01 NS32228- ninds

U01NS032228

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)

Ortho Biotech Clinical Affairs, L.L.C.

PPD