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

SIGMA-TA0 个研究点目标入组 40 人开始时间: 2006年4月21日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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.

发起方

SIGMA-TA