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A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT05005078•WinSanTor, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients are eligible for the study if all the following criteria are met:
•1. HIV infection documented by serologic testing at screening; virally suppressed on ART.
•2. Male and female patients in the age range of 18 to 80 years (inclusive).
•3. Diagnosis of HIV-DSP determined by a neurological exam performed by qualified personnel and defined as one or more clinical signs (symmetrical, diminished distal vibration or dull/sharp sensation in feet or reduced ankle reflexes using HNRC CH40);
•4. Baseline IENF density \<5%ile (ankle) based on age- and sex-adjusted Lauria norms.
•5. Provide written informed consent prior to entering the study or undergoing any study procedures.
•6. Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and must be practicing a highly effective medically acceptable method of contraception, including abstinence; hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; or vasectomy (partner), for at least 1 month before the screening visit and for 1 month after the end of the last dose of study drug. If access or use of a highly effective medically acceptable method of contraception is not achievable, then a combination of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) is acceptable. Eligible female subjects must also have a negative serum beta-human chorionic gonadotropin at the screening visit.
•7. Males must use an acceptable form of contraception (e.g., male condom with diaphragm, male condom with cervical cap, or male condom in association with spermicide).
•8. If diabetic, glycemic control has been optimized and has been stable for at least three months prior to randomization. Optimal glycemic control (by HgbA1C\<7; at discretion of PI) refers to the best possible diabetic control that an individual patient can attain with usual standards of care, which usually takes more than two months to establish.
•9. Participating subjects must be reliable, willing, and able to cooperate with all study procedures, including the following:
+9 more criteria

Exclusion Criteria

•1. Current intoxication (BAC \> 0.08%) at the screening visit at the discretion of the investigator (breathalyzer analysis).
•2. Neuropathy due to exposure to current use/ chemotherapeutic agents or other neurotoxins; at the discretion of the investigator.
•3. Individuals with the onset of Type 2 diabetes mellitus before HIV infection.
•4. Uncontrolled or Insulin-dependent diabetes mellitus.
•5. Proliferative retinopathy or maculopathy requiring acute treatment.
•6. Requiring dialysis. Impaired liver function, defined as aspartate aminotransferase or alanineaminotransferase \> 3 times the upper limit of normal.
•7. Presence of clinically significant peripheral or autonomic neuropathy that is clearly of non HIVN origin.
•8. Active and/or systemic infections with hepatitis C (as per investigator judgement following serology results) or syphilis, or a history of severe infection during the 30 days prior to screening.
•9. Diagnosis and/or treatment of malignancy (except for basal cell or squamous cell skin cancer, in-situ carcinoma of the cervix, or in-situ prostate cancer) within the past 5 years.
•10. Clinically significant diagnosed gastric emptying abnormality (e.g., severe gastroparesis).
+24 more criteria

Locations (2)

Palmtree Clinical Research

Palm Springs, California, United States

University of California San Diego

San Diego, California, United States

Key Dates

Start Date

February 24, 2022

Primary Completion Date

January 18, 2023

Completion Date

January 24, 2023

Last Updated

December 4, 2023

Enrollment

ACTUAL participants

Conditions

HIV Associated Polyneuropathy

Interventions

WST-057

DRUG

Placebo

DRUG