NCT00225160

ALCAR Prophylaxis Study

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Royal Free Hampstead NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HIV Infections
• Distal Symmetric Polyneuropathy

Interventions

Type	Name	Description
DRUG	acetyl L-carnitine

Timeline

• Start date: 2003-11-01
• First posted: 2005-09-23
• Last updated: 2008-09-18

Locations

1 site across 1 country: United Kingdom