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

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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources




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.


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286377


Sponsors and Collaborators
Savient Pharmaceuticals
Neurologic AIDS Research Consortium (NARC)
Investigators
Study Director: Claudia Rehrig, MS Savient Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00286377     History of Changes
Other Study ID Numbers: C0603
NARC # 009
First Posted: February 3, 2006    Key Record Dates
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