NCT00528593

Epoetin Alfa for HIV-Associated Neuropathy Trial

A Randomized, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-associated Sensory Neuropathy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infections
• Neuropathy

Interventions

Type	Name	Description
DRUG	epoetin alfa	Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-09-12
• Last updated: 2011-08-09