Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margaret A Johnson

ORCID ID

Contact details

Department of Infection & Immunity
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7794 0500 ext 3082
Sally.Allen@royalfree.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256146998

Study information

Scientific title

Randomised, double-blind, placebo controlled, study to evaluate the safety and efficacy of acetyl L-carnitine (ALCAR), in combination with antiretroviral therapy, for prevention of distal symmetric polyneuropathy (DSP) and lipid abnormalities in treatment of human immunodeficiency virus (HIV)

Acronym

Study hypothesis

Does the use of acetyl L-carnitine (ALCAR) prevent the occurrence of distal symmetric polyneuropathy (DSP) (a side effect of antiretroviral therapy)?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Distal symmetric polyneuropathy (DSP)

Intervention

Randomised controlled trial

Intervention type

Drug

Phase

Not Specified

Drug names

Acetyl L-carnitine

Primary outcome measures

Primary endpoint: the change in baseline in total area of PGP (protein gene product) immunostaining on the epidermis at 48 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

40 patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Infection & Immunity
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The Royal Free Hampstead NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.