Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

• Drug: pregabalin
  
  Pregabalin 75 mg-300mg twice daily during the course of the study.
• Drug: placebo
  
  Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.

• Experimental: Active drug
  
  Intervention: Drug: pregabalin
• Placebo Comparator: Control
  
  Intervention: Drug: placebo

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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