ALCAR Prophylaxis Study - Full Text View

Sponsor:	Royal Free Hampstead NHS Trust
Collaborators:	Bristol-Myers Squibb Sigma-Tau Research, Inc.
Information provided by:	Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:	NCT00225160

Purpose

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

Condition	Intervention	Phase
HIV Infections Distal Symmetric Polyneuropathy	Drug: acetyl L-carnitine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Carnitine

U.S. FDA Resources

Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:

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

Secondary Outcome Measures:

-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
-Time to discontinuation of the randomised treatment and reasons for this
-Incidence of adverse events
-Incidence of clinical disease progression
-Proportion of patients at Weeks 24 and 48 and incidence of virological and clinical failure or treatment-limiting adverse events
-Proportion of patients with changes in lipid profiles
-Change in body habitus as measured by lipodystrophy questionnaire
-Change in QOL at Weeks 24 and 48
-Changes in subcutaneous adipose tissue mtDNA

Estimated Enrollment:	50
Study Start Date:	November 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225160

Locations

United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Royal Free Hampstead NHS Trust

Bristol-Myers Squibb

Sigma-Tau Research, Inc.

Investigators

Principal Investigator:

Armin - Rieger, MD

University of Vienna Medical School AKH

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00225160 History of Changes
Other Study ID Numbers:	ALCAR
Study First Received:	September 21, 2005
Last Updated:	September 17, 2008
Health Authority:	United Kingdom: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Dataprotection Agency; Austria: Federal Ministry for Health and Women

Keywords provided by Royal Free Hampstead NHS Trust:

HIV
poly neuropathy
acetyl L-carnitine

treatment naïve
combination antiretroviral therapy
Lipid abnormalities

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Polyneuropathies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Peripheral Nervous System Diseases

Neuromuscular Diseases
Nervous System Diseases
Acetylcarnitine
Carnitine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012