Epoetin Alfa for HIV-Associated Neuropathy Trial

This study has been withdrawn prior to enrollment.
(lack of pharmaceutical support)
Sponsor:
Collaborators:
Ortho Biotech Clinical Affairs, L.L.C.
PPD
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00528593
First received: September 11, 2007
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
HIV Infections
Neuropathy
Drug: epoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Difference between the distal leg intra-epidermal nerve fiber density [ Time Frame: at baseline and after 48 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Differences between Quantitative Sensory Testing measurement at baseline and after 48 weeks of treatment [ Time Frame: at baseline and after 48 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: epoetin alfa
Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
Other Names:
  • Procrit
  • erythropoetin

Detailed Description:

The Neurologic AIDS Research Consortium (NARC) designs and carries out clinical trials to improve the therapy for HIV induced neurologic disease, and neurologic conditions associated with the AIDS virus.

Complications of HIV are dynamically evolving over time. In general, neurologic complications that typically occur in advanced disease stages are increasing in incidence while some of the early complications associated with AIDS are less commonly found due to improved preventive therapy. The impact of the new generation of antiretroviral drugs, and of predominantly multi-drug therapy remain to be seen. Several key new drugs fail to penetrate the brain, thus making it possible for the incidence of neurologic disease to continue to increase. NARC develops studies based on the current challenges of the AIDS epidemic.

Erythropoetin (also known as epoetin alfa or Procrit) is naturally produced in the body. Procrit or epoetin alfa is an injectable form of synthetic erythropoietin. In this trial, scientists will evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings. The goal of the trial is to determine if epoetin alfa increases the number of nerve fibers in the skin of people with HIV-associated neuropathy, and improves symptoms of neuropathy. This study will also find out if Procrit is safe and well-tolerated for treating the painful neuropathy associated with HIV.

After two screening visits, participants will be randomly assigned to one of two groups: group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week. Follow-up treatment visits will occur at weeks 6, 12, 24, 36, and 48. During the visits, participants will have their blood pressure and heart rate measured. During several of the follow-up visits participants will be asked to rate the intensity of their pain using the Gracely Pain Scale and the McGill Pain Questionnaire. Duration of this trial for participants is 52 weeks or 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528593

Sponsors and Collaborators
Washington University School of Medicine
Ortho Biotech Clinical Affairs, L.L.C.
PPD
Investigators
Study Chair: Justin McArthur, MBBS, MPH Professor of Neurology, Johns Hopkins University
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: David B. Clifford, M.D., Principal Investigator, Neurologic AIDS Research Consortium, Washington University
ClinicalTrials.gov Identifier: NCT00528593     History of Changes
Other Study ID Numbers: U01 NS32228- ninds, U01NS032228
Study First Received: September 11, 2007
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
HIV
AIDS
neuropathy
Procrit
epoetin alfa
erythropoetin
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Peripheral Nervous System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neuromuscular Diseases
Nervous System Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014