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

Recruiting at 2 trial locations

Overseen By Daniel Vincent, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: WinSanTor, Inc

Must be taking: Antiretrovirals

Must not be taking: Anticholinergics, Antispasmodics

Disqualifiers: Diabetes, Hepatitis C, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical cream with pirenzepine for HIV patients who have nerve pain. The cream aims to reduce pain by blocking pain signals. The study will check if the cream is safe and effective over a few months.

Who Is on the Research Team?

Angela Hansen

Principal Investigator

WinSanTor, Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Return for study visits on the required dates

Prior week VAS for average pain/discomfort (altered sensation) and/or altered sensations on lower extremities > 20 mm and < 80mm (0 mm = no pain-100 mm = very severe pain) at screening.

Exclusion Criteria

You have skin or soft-tissue lesions on your calves, ankles, or tops of feet that are painful or could affect feeling.

Any open wound(s) and/or sunburn(s) in the dosing area. Subjects who have a wound and/or sunburn at screening that is anticipated to resolve before day -1 can be enrolled.

You have not taken any new or experimental drugs, biologics, or medical devices in the past 3 months before screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments and stratification based on pain scores using the Visual Analog Scale (VAS)

1 day

1 visit (in-person)

Treatment

Participants receive daily topical dosing of WST-057 or placebo for 16 weeks

16 weeks

Visits at Day 0, Weeks 4, 8, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person) at Week 18

What Are the Treatments Tested in This Trial?

Interventions

• WST-057

How Is the Trial Designed?

Group I: WST-057 Experimental Treatment 1 Intervention

WST-057 topical solution

Group II: Placebo Placebo Group 2 Interventions

WST-057 Matching placebo

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials

4

Recruited

190+