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

Sponsors and Collaborators:	Savient Pharmaceuticals Neurologic AIDS Research Consortium (NARC)
Information provided by:	Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00286377

Purpose

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	Intervention	Phase
HIV Peripheral Nervous System Disorders	Drug: prosaptide	Phase II

MedlinePlus related topics: AIDS Neurologic Diseases Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Savient Pharmaceuticals:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	350
Study Start Date:	September 2003
Estimated Study Completion Date:	December 2004

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Ages 18 years and older

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286377

Sponsors and Collaborators

Savient Pharmaceuticals

Neurologic AIDS Research Consortium (NARC)

Investigators

Study Director:

Claudia Rehrig, MS

Savient Pharmaceuticals, Inc.

More Information

No publications provided

Study ID Numbers:	C0603, NARC # 009
Study First Received:	June 30, 2005
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00286377 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuromuscular Diseases
HIV Seropositivity
HIV Infections

Peripheral Nervous System Diseases
Acquired Immunodeficiency Syndrome
Pain

Additional relevant MeSH terms:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 07, 2009