Epoetin Alfa for HIV-Associated Neuropathy Trial

NCT00528593 | Withdrawn Phase 2

• 2 other identifiers: U01 NS32228- nindsU01NS032228
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections; Neuropathy

Keywords

HIV; AIDS; neuropathy; Procrit; epoetin alfa; erythropoetin; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Difference between the distal leg intra-epidermal nerve fiber density

  at baseline and after 48 weeks of treatment

Secondary Outcomes (3)

• Change in pain levels measured via Gracely pain scale between baseline and every 6 weeks thereafter up to 48 weeks

  up to 48 weeks

• 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

• Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment

  at baseline and after 48 weeks of treatment

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: epoetin alfa

Interventions

epoetin alfa DRUG

Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.

Also known as: Procrit, erythropoetin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator
• PPD Development, LP: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Epoetin Alfa; Erythropoietin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Justin McArthur, MBBS, MPH

  Professor of Neurology, Johns Hopkins University

  STUDY CHAIR

• David B. Clifford, MD

  Professor of Neurology, Washington University

  PRINCIPAL INVESTIGATOR

• David Simpson, MD

  Professor of Neurology, Mt. Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Bruce Cohen, MD

  Professor of Neurology, Northwestern University

  PRINCIPAL INVESTIGATOR

• Pablo Tebas, MD

  Associate Professor of Medicine, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 9, 2011

Record last verified: 2011-08