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ALCAR Prophylaxis Study

Primary Purpose

HIV Infections, Distal Symmetric Polyneuropathy

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
acetyl L-carnitine
Sponsored by
Royal Free Hampstead NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, poly neuropathy, acetyl L-carnitine, treatment naïve, combination antiretroviral therapy, Lipid abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Free Hospital

Outcomes

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

Full Information

First Posted
September 21, 2005
Last Updated
September 17, 2008
Sponsor
Royal Free Hampstead NHS Trust
Collaborators
Bristol-Myers Squibb, Sigma-Tau Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00225160
Brief Title
ALCAR Prophylaxis Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Free Hampstead NHS Trust
Collaborators
Bristol-Myers Squibb, Sigma-Tau Research, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Distal Symmetric Polyneuropathy
Keywords
HIV, poly neuropathy, acetyl L-carnitine, treatment naïve, combination antiretroviral therapy, Lipid abnormalities

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
acetyl L-carnitine
Primary Outcome Measure Information:
Title
The change from baseline in total area of Protein Gene Product (PGP) immunostaining on the epidermis at 48 weeks
Secondary Outcome Measure Information:
Title
-Proportion of patients requiring analgesic agents
Title
-Changes in the global assessments of pain by both subject and investigator
Title
-Proportion of patients with HIV-1 RNA < 50 copies/ml at 24 and 48 weeks
Title
-Proportion of patients with virological failure at 24 and 48 weeks
Title
-Changes in CD4+ cell count from baseline after 24 and 48 weeks of treatment
Title
-Time to discontinuation of the randomised treatment and reasons for this
Title
-Incidence of adverse events
Title
-Incidence of clinical disease progression
Title
-Proportion of patients at Weeks 24 and 48 and incidence of virological and clinical failure or treatment-limiting adverse events
Title
-Proportion of patients with changes in lipid profiles
Title
-Change in body habitus as measured by lipodystrophy questionnaire
Title
-Change in QOL at Weeks 24 and 48
Title
-Changes in subcutaneous adipose tissue mtDNA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin - Rieger, MD
Organizational Affiliation
University of Vienna Medical School AKH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

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ALCAR Prophylaxis Study

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