HIV Infections Clinical Trial
Official title:
A Randomised Double Blinded Placebo Controlled Pilot Study to Evaluate the Safety and Efficacy of Acetyl L Carnitine in Combination With Antiretroviral Therapy for the Prevention of Distal Symmetric Polyneuropathy and Lipid Abnormalities in Treatment naïve HIV Infected Subjects
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
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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