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

• ClinicalTrials.gov Identifier: NCT00286377
• Recruitment Status: Terminated
• First Posted: February 3, 2006
• Last Update Posted: February 3, 2006
• Sponsor: Savient Pharmaceuticals
• Collaborator: Neurologic AIDS Research Consortium (NARC)
• Information provided by: Savient Pharmaceuticals

Tracking Information

• First Submitted Date: June 30, 2005
• First Posted Date: February 3, 2006
• Last Update Posted Date: February 3, 2006
• Study Start Date: September 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: February 2, 2006): 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
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 2, 2006)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
• 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
• Brief Summary: 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.

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

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• HIV
• Peripheral Nervous System Disorders

• Intervention: Drug: prosaptide
• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: February 2, 2006): 350
• Original Enrollment: Same as current
• Study Completion Date: December 2004
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Ages 18 years and older

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00286377
• Other Study ID Numbers: C0603; NARC # 009
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Savient Pharmaceuticals
• Collaborators: Neurologic AIDS Research Consortium (NARC)

Investigators

• Study Director: Claudia Rehrig, MS; Savient Pharmaceuticals, Inc.

• PRS Account: Savient Pharmaceuticals
• Verification Date: January 2006