Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT00225160
Status:
UNKNOWN
Last Update Posted:
2008-09-18
First Post:
2005-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALCAR Prophylaxis Study
Sponsor:
Royal Free Hampstead NHS Trust
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: