HIV Infections Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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