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ALCAR Prophylaxis Study

NCT00225160 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-09-18

No results posted yet for this study

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

DRUG

acetyl L-carnitine

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sigma-Tau Research, Inc.

    collaborator INDUSTRY

  • Royal Free Hampstead NHS Trust

    lead OTHER

Principal Investigators

  • Armin - Rieger, MD · University of Vienna Medical School AKH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225160 on ClinicalTrials.gov