Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients
- Conditions
- HIVPeripheral Nervous System Disorders
- Registration Number
- NCT00286377
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 350
- Ages 18 years and older
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.