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)
| ISRCTN | ISRCTN58811572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58811572 |
| Secondary identifying numbers | N0256146998 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Margaret A Johnson
Scientific
Scientific
Department of Infection & Immunity
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
| Phone | +44 (0)20 7794 0500 ext 3082 |
|---|---|
| Sally.Allen@royalfree.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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) |
| Study objectives | Does the use of acetyl L-carnitine (ALCAR) prevent the occurrence of distal symmetric polyneuropathy (DSP) (a side effect of antiretroviral therapy)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Distal symmetric polyneuropathy (DSP) |
| Intervention | Randomised controlled trial |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Acetyl L-carnitine |
| Primary outcome measure | 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 study start date | 01/11/2002 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | 40 patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Infection & Immunity
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Royal Free Hampstead NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
