C0603 Prosaptide

A study testing the safety and effectiveness of a new medication called prosaptide for the relief of HIV/AIDS-associated neuropathic pain.

 

 

Background

Neuropathy affects over 30‰ of the people with advanced HIV disease. There is a need for effective neuropathy treatments that focus on reparative mechanisms while alleviating pain.

Objective

 

This study looks at the pain reduction, safety, tolerability and pharmacokinetics (amount of drug in recipient’s blood) of prosaptide versus placebo. In addition, the study will determine whether prosaptide has sensory reparative properties, as determined by neurological examinations, including nerve conduction studies conducted on site.

 

 

 

Study
Design

 

Volunteers will be randomly assigned to one of four dosing groups. Volunteers must be willing to stop their current neuropathy treatment for the duration of the study, and they will be compensated up to $50 per visit.

No volunteer will receive placebo.

 

Inclusion
Criteria

(partial list)

HIV+ adult male or female
Diagnosis of painful HIV-associated neuropathy in both feet
Currently using ddI, d4T or ddC > 4 months OR not currently using ddI, d4T or ddC


Status
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Enrolling
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For more information about participating in this study in the Los Angeles area, please call 310.358.2429 or e-mail Corie Castro at ccastro@aidsresearch.org

We encourage participation by women and people of color.

This ad was reviewed and approved by the AIDS ReSearch Alliance Institutional Review Board in October, 2003.

 


 

 

Copyright © 2003 AIDS Research Alliance of America
All Rights Reserved

 
 
 
 
 
 
 
 
 
 
 
 

 

 

 

 

 

 

 

 

 

 

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