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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-004665-42-IT
Date of registration:	21/04/2006
Prospective Registration:	No
Primary sponsor:	SIGMA-TAU
Public title:	Evaluation of the efficacy and tollerability of long-term somministration of Acetyl-l-carnitine in the treatment of HIV related lipodystrophy.Parallel group, randomized, double blind, controlled versus placebo study. - ND
Scientific title:	Evaluation of the efficacy and tollerability of long-term somministration of Acetyl-l-carnitine in the treatment of HIV related lipodystrophy.Parallel group, randomized, double blind, controlled versus placebo study. - ND
Date of first enrolment:	17/03/2006
Target sample size:	40
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004665-42
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Italy

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
The subjects will be enrolled in the study only if they match all the following criteria 1 documented diagnosis of HIV infection. 2 more than 18 years of age. 3 at least 6 months of stable antiretroviral therapy, without thymidine s analogous. 4 diagnosis of Lipodystrophy. 5 HOMA s value 2. 6 Lipodystrophy defined with DEXA s analysis. 7 willingness of being monitorized for at least 52 weeks. 8 signed the Written Consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The patients will not be enrolled in the study if they match any of this criteria 1 any concomitant infection. 2 antiretroviral therapy with Stavudina D4T or zidovudina AZT . 3 if affected from diabetes mellitus or alteration of the funcionality of the thyroid gland. 4 any pathology that could cause malabsorption. 5 evidence of any cronic pathology within internal medicine. 6 pregnancy or breastfeeding. 7 known or suspected hypersensibility to L-carnitine or its derivatives. 8 treatment with L-carnitine or its derivatives in the six months before the beginning of the trial. 9 enrollement in other clinical trials in the 3 months previous to the beginning of the study.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV related LIPODYSTROPHY.
MedDRA version: 6.1 Level: PT Classification code 10061624

Intervention(s)

Product Name: ACETYL- L- CARNITINE
Product Code: ST200
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: Acetylcarnitine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Granules for oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study are 1 variation of the percentage of the adipose tissue in the inferior arts with DEXA. 2 variation of the score of Lipodystrophy Case Definition LDCD according with the Carr classification. 3 variation of some metabolic values. 4 variation of the score of the life quality scale Medical Outcome Study MOS-HIV 52 . 5 variation of the concentration of adiponectina and leptina. 6 gene expression s modification of the RNAm for proteins of the carnitine s sistem. 7 evaluation of the tollerability and safety of the somministration of Acetyl-l-carnitine 3 g/die for 48 weeks .

Primary end point(s): According to the objectives, the primary end points will be the modifications of the metabolic parameters HOMA and of the content of mitochondrional DNA of the CD4 and CD8 due to the treatment with L-acetylcarnitine.

Main Objective: The objective of this study is the evaluation of the efficacy and tollerability of Acetyl-l-carnitine administrated in the dose of 3 g/die for 48 weeks in patients affected by HIV related lipodystrophy. The primary objective consists in the variation of the following parameters a Homeostasis Model of Assessment HOMA , that is the evaluation of the ratio between glycemia in mmol/L and insulinemia in micronU/mL calculated with the following formula glycemia insulinemia /22.5 b content of mitochondrional DNA of the CD4 and CD8.

Secondary Outcome(s)

Secondary ID(s)

ST 200 DS 05-002

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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