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

This study has been terminated.
Sponsor:
Collaborator:
Neurologic AIDS Research Consortium (NARC)
Information provided by:
Savient Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00286377
First received: June 30, 2005
Last updated: February 2, 2006
Last verified: January 2006
History of Changes

June 30, 2005
February 2, 2006
September 2003
Not Provided
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
Same as current
Complete list of historical versions of study NCT00286377 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
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

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV
  • Peripheral Nervous System Disorders
Drug: prosaptide
Not Provided
Evans SR, Simpson DM, Kitch DW, King A, Clifford DB, Cohen BA, McArthur JC; Neurologic AIDS Research Consortium; AIDS Clinical Trials Group. A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain. PLoS One. 2007 Jul 25;2(6):e551.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
350
December 2004
Not Provided

Inclusion Criteria:

  • Ages 18 years and older
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00286377
C0603, NARC # 009
Not Provided
Not Provided
Savient Pharmaceuticals
Neurologic AIDS Research Consortium (NARC)
Study Director: Claudia Rehrig, MS Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP