HIV, Peripheral Nervous System Disorders
Conditions
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
Interventions
DRUGprosaptide
Sponsors
Neurologic AIDS Research Consortium (NARC)
Savient Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 years and older
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed