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Clinical Trial Summary

The purpose of this study is to determine whether Acetyl L-carnitine can prevent the development of nerve damage, known as neuropathy, in individuals taking anti-HIV drugs over a 48-week period. In addition the safety and tolerability of Acetyl L-carnitine will be assessed.

This study compares the use of Acetyl L-carnitine or placebo (a dummy drug) in the prevention of nerve damage. The current standard of care is to use painkillers to manage the pain, with little or no effect. The possible beneficial effects of taking Acetyl L-carnitine is to prevent nerve damage as a result of anti-HIV medication.

The main purposes of the trial are:

- to look at the differences in between those on Acetyl L-carnitine versus those on placebo

- to look at the effect on state of your nervous system in the two treatment groups by measuring nerve activity

- to learn more about the safety and tolerance of Acetyl L-carnitine


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00225160
Study type Interventional
Source Royal Free Hampstead NHS Trust
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 2003

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