Health Condition 1: null- Neuropathic pain associated with HIV Neuropathy
Conditions
Interventions
Intervention1: Experimental drug: pregabalin: Pregabalin 75 mg-300mg twice daily during the course of the study.
Control Intervention1: Placebo Comparator: Subjects may be assigned to placebo during
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women, ages of 18 or greater 2. Documented evidence of HIV-1 infection 3. Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain 4. Pain starts in the feet Note: there is no upper age limit for inclusion criteria for this protocol
Exclusion criteria
Exclusion criteria: 1. 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 2. Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint mean pain score derived from subject's diary for daily average pain on an 11 point pain numeric rating scale (NRS-Average)Timepoint: Daily | — |
Secondary
| Measure | Time frame |
|---|---|
| (PHQ-8);Diagnostic Neuropathy WorksheetTimepoint: First Visit;Actigraphy Functional/Sleep AssessmentTimepoint: Daily;Adverse Event monitoring throughout the trialTimepoint: At all visits through Week 17;Brief Pain Inventory-Short Form (BPI-sf)Timepoint: Monthly;Clinician Global Impression of Change (CGIC)Timepoint: Week 16;Daily NRS Current Pain (NRS Current )Timepoint: Daily;Daily NRS Sleep Interference (NRS-Sleep)Timepoint: Daily;Hospital Anxiety and Depression Scale (HADS)Timepoint: Week 1 and Week 16;Laboratory testing including hematology, chemistry, CD4 count and CD8 count, HIV plasma viral load, B12, VDRL, toxic screens drugs for drugs and alcohol, reflex TSH, urinalysisTimepoint: First visit and Week 17;Medical Outcomes Survey (MOS)-Sleep ScaleTimepoint: Week 1 and Week 16;Mini-International Neuropsychiatric Interview (MINI) Modules (depression, mania, substance abuse/dependence, and psychosis modules);Sheehan-Suicidality Tracking Scale (SSTS); Patient Health Questionnaire-8Timepoint: First Visit;Neurological examinationTimepoint: First Visit;Neuropathic Pain Symptom Inventory (NPSI)Timepoint: Week 1 and Week 16;Patient Global Impression of Change (PGIC)Timepoint: Week 16;Physical Examination and vital signsTimepoint: Week 1, Week 8, and Week 17;Serum pregnancy testing at screening urine pregnancy test (and as clinically indicated during study)Timepoint: First visit and Week 1;SF-36Timepoint: Week 1 and Week 16 | — |
Countries
Colombia, Czech Republic, Dominican Republic, India, Kenya, Peru, Poland, South Africa, Thailand, Uganda, United States of America
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed