NCT05005078

A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV

A 16-Week Phase 2a Study of Topical Pirenzepine (WST-057) or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy (DSP) in Patients With HIV (PWH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: WinSanTor, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part study of the safety, tolerability, and efficacy of topically administered WST-057 for 16 weeks in subjects with HIV with sensory polyneuropathy.

Detailed description

Phase A: Is an open-labeled feasibility investigation of the safety, tolerability, and limited efficacy in 14 subjects with HIV-associated distal sensory polyneuropathy (HIV-DSP) after topical daily dosing of WST-057 (4% pirenzepine free base monohydrate). Subjects will be stratified based on their baseline scores for pain/discomfort using the Visual Analog Scale (VAS). Subjects will attend visits at screening; Day 0 (baseline); Weeks 4, 8, and 16; and follow-up (Week 18). Phase B: Is a randomized outpatient, double-blind, placebo-controlled, single-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 for 16 weeks in subjects with HIV-associated distal sensory polyneuropathy (HIV-DSP). Stratification of subjects based on baseline pain will be included based on the results of Part A. Subjects will attend visits at screening; Day 0 (baseline); Weeks 4, 8, and 16; and follow-up (Week 18). Approximately 60 subjects with HIV-DSP will be randomized to 1 of 2 treatment groups in a 3:2 ratio: WST-057 (4 mL) (n = 36 subjects) versus placebo control 4 mL (n = 24 subjects); with the assumption that a total of 50 subjects will complete the study. This study is designed with 4 periods in both study phases: screening, baseline/day 0, outpatient treatment, and safety follow-up.

Conditions

• HIV Associated Polyneuropathy

Interventions

Type	Name	Description
DRUG	WST-057	WST-057 topical solution
DRUG	Placebo	WST-057 Matching placebo

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-01-18
• Completion: 2023-01-24
• First posted: 2021-08-13
• Last updated: 2023-12-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study