Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225160
Status:
UNKNOWN
Last Update Posted:
2008-09-18
First Post:
2005-09-21
Brief Title:
ALCAR Prophylaxis Study
Sponsor:
Royal Free Hampstead NHS Trust
Organization:
Royal Free Hampstead NHS Trust
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None