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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV; Peripheral Nervous System Disorders	Drug: prosaptide	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	350 participants
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
Study Start Date :	September 2003
Study Completion Date :	December 2004

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Difference between the Beline pain rating and each week of treatment.
2. Number of subjects whoe were treatment successes at each week of the active treatment period.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Ages 18 years and older

Contacts and Locations

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Sponsors and Collaborators

Savient Pharmaceuticals

Neurologic AIDS Research Consortium (NARC)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00286377 History of Changes
Other Study ID Numbers:	C0603; NARC # 009
First Posted:	February 3, 2006
Last Update Posted:	February 3, 2006
Last Verified:	January 2006

Additional relevant MeSH terms:

Neuralgia; Nervous System Diseases; Peripheral Nervous System Diseases; Pain	Neurologic Manifestations; Neuromuscular Diseases; Signs and Symptoms