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

Phase 2

Waitlist Available

Research Sponsored by WinSanTor, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

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.

Eligible Conditions

HIV-associated Neuropathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)

Incidence of Treatment Emergent Adverse Events as assessed by dermal assessment (Draize score 0.0-4.0) score of skin erythema, edema pruritus and dryness score) of the dosing area

Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests

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Secondary study objectives

IENFD change from baseline for both treated and untreated skin

Medical Outcomes Study HIV Health Survey (MOS-HIV)

Neuropathic Pain Scale-10 (NPS-10)

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