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

HIV Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00286377
• Other study ID #: C0603
• Secondary ID: NARC # 009
• Status: Terminated
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: February 2, 2006
• Start date: September 2003
• Est. completion date: December 2004

Study information

• Verified date: January 2006
• Source: Savient Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 years and older

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Nervous System Diseases
• Neuralgia
• Peripheral Nervous System Diseases
• Peripheral Nervous System Disorders

Intervention

Drug:
• prosaptide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Savient Pharmaceuticals	Neurologic AIDS Research Consortium (NARC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between the Beline pain rating and each week of treatment.
Secondary	Number of subjects whoe were treatment successes at each week of the active treatment period.