- Men and women, ages of 18 or greater
- Documented evidence of HIV-1 infection
- Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with
subjective sensory symptom of pain
- Pain starts in the feet
- Subject has untreated vitamin B12 deficiency (serum B12 level
treated B12 deficiency -treatment is less than 6 months of B12 supplementation
(injection or intranasal B12) prior to screening
- Diabetes mellitus requiring regular medical treatment (other than diet and exercise)
or HbA1C >6.9
- Subjects with peripheral neuropathic pain that is not associated with HIV infection;
including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic
Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy,
radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related
to: metabolic abnormalities; nutritional factors; vascular insults; inflammation;
autoimmune disease; and malignancy