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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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

Conditions

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HIV Peripheral Nervous System Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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prosaptide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18 years and older

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Claudia Rehrig, MS

Role: STUDY_DIRECTOR

Savient Pharmaceuticals, Inc.

References

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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. doi: 10.1371/journal.pone.0000551.

Reference Type DERIVED

PMID: 17653259 (View on PubMed)

Other Identifiers

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NARC # 009

Identifier Type: -

Identifier Source: secondary_id

C0603