Lead Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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 \<200 pg/ml) or if 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

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