This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients

This study has been terminated.
Neurologic AIDS Research Consortium (NARC)
Information provided by:
Savient Pharmaceuticals Identifier:
First received: June 30, 2005
Last updated: February 2, 2006
Last verified: January 2006
This is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their HIV infection or the drugs used to treat it.

Condition Intervention Phase
HIV Peripheral Nervous System Disorders Drug: prosaptide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1

Resource links provided by NLM:

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:
  • Differnece between the pain rating at Baseline vs. Week 6 (or last week)of treatment, based on the 13-point Gracely pain intensity scale as rated by subjects and captured in an electronic diary

Secondary Outcome Measures:
  • Difference between the Beline pain rating and each week of treatment.
  • Number of subjects whoe were treatment successes at each week of the active treatment period.

Estimated Enrollment: 350
Study Start Date: September 2003
Estimated Study Completion Date: December 2004
Detailed Description:

Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens.

In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms.

Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects.

Comparisons: 4, 8, or 16 mg prosaptide vs. placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18 years and older
  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 identifier: NCT00286377

Sponsors and Collaborators
Savient Pharmaceuticals
Neurologic AIDS Research Consortium (NARC)
Study Director: Claudia Rehrig, MS Savient Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00286377     History of Changes
Other Study ID Numbers: C0603
NARC # 009
Study First Received: June 30, 2005
Last Updated: February 2, 2006

Additional relevant MeSH terms:
Nervous System Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms processed this record on September 21, 2017