Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.

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Detailed Description

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Conditions

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HIV Infections Peripheral Nervous System Diseases Pain

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Capsaicin Dermal Patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Key Eligibility Criteria:

* Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
* Must not have significant pain in feet due to other causes (for example, arthritis).
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).
* Must not use topical pain medications for HIV-associated neuropathy.
* Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
* Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.
* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
* No history or current problem with substance abuse.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No