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
- Conditions
- HIV related LIPODYSTROPHY.MedDRA version: 6.1Level: PTClassification code 10061624
- Registration Number
- EUCTR2005-004665-42-IT
- Lead Sponsor
- SIGMA-TA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method