ALCAR Prophylaxis Study

NCT ID: NCT00225160

Last Updated: 2008-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30

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

Conditions

HIV Infections; Distal Symmetric Polyneuropathy

Keywords

HIV; poly neuropathy; acetyl L-carnitine; treatment naïve; combination antiretroviral therapy; Lipid abnormalities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

acetyl L-carnitine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged > 18 years of age
• HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
• Women of childbearing potential must have a negative serum (beta-HCG; performed by a medical doctor - Austria only) pregnancy test within 28 days of starting study drug (and at monthly intervals for the duration for the trial (-Austria only)
• Ability to assess level of pain and complete a pain log
• Ability to understand and provide written informed consent to participation in this trial
• All clinical laboratory values must be considered not clinically significant - for the potential response to the planned new regimen - in the opinion of the investigator
• Naïve to antiretroviral therapy

Exclusion Criteria

• Diminished ankle reflexes (compared to the knee) or absent ankle reflexes. OR
• Distal diminution of either vibration sense in the legs (defined as perception vibration < 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) or pain or temperature sensation.
• Subjects who in the investigator's opinion are unlikely to complete the 48 weeks trial period.
• Subjects with current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations.
• Previous treatment with any drug known to induce peripheral neuropathy, specifically excessive alcohol, isoniazid & vincristine.
• Subjects with insulin dependent diabetes or cancer and an existing peripheral neuropathy or hereditary neuropathy.
• Subjects with Vitamin B 12 deficiency (level < 150pg/mL)
• Subjects using neurotoxic systemic therapeutic agents, systemic corticosteroids or immunomodulators within 30 days of randomisation.
• Use of a medication for neuropathic pain during 2 weeks prior to randomisation (including tricyclic antidepressants, mexilitene, phenytoin or carbamazepine).
• Subjects who have taken L-carnitine within 6 last months, or who have ever taken ALCAR.
• Subjects being pregnant or breast feeding.
• Subjects suffering from a serious medical condition, including one or more AIDS defining events (Appendix 8), which in the opinion of the investigator, would compromise the safety of the subject

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sigma-Tau Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Royal Free Hampstead NHS Trust

OTHER

Sponsor Role: lead

Principal Investigators

Armin - Rieger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vienna Medical School AKH

Locations

Royal Free Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

ALCAR

Identifier Type: -

Identifier Source: org_study_id