ALCAR Prophylaxis Study

NCT00225160 | Unknown Phase 2

• 1 other identifier: ALCAR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 48 weeks

Secondary Outcomes (13)

• -Proportion of patients requiring analgesic agents

• -Changes in the global assessments of pain by both subject and investigator

• -Proportion of patients with HIV-1 RNA < 50 copies/ml at 24 and 48 weeks

• -Proportion of patients with virological failure at 24 and 48 weeks

• -Changes in CD4+ cell count from baseline after 24 and 48 weeks of treatment

Interventions

acetyl L-carnitine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hampstead NHS Trust: lead
• Bristol-Myers Squibb: collaborator
• Sigma-Tau Research, Inc.: collaborator

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Armin - Rieger, MD

  University of Vienna Medical School AKH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: November 1, 2003
• Last Updated: September 18, 2008

Record last verified: 2008-09

Locations

GB (1)