Epoetin Alfa for HIV-Associated Neuropathy Trial
|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|
- 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 ]
- 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Drug: epoetin alfa
Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528593
|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|