Phase IV-III, open-label, randomized, comparative study, to evaluate the safety and efficacy of the nucleoside supression of a triple therapy based on lopinavir-ritonavir vs. continuous triple therapy on patients infected by HIV that have maintained undetectable HIV viral load during 6 months. OK2004 - OK2004

H. 12 de Octubre0 个研究点开始时间: 2004年11月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•.- HIV patients over 18 years old who are currently receiving treatment with two nucleosides (or 1 nuc + TDF) and Kaletra and with the confirmation of viral load less than 50 copies/ml during the six months previous to the inclusion in the study. At least two viral loads < 50 copies/ml separated at least 6 months and non > 50 copies/ml during the 6 months previous to the inclusion are required.
•.- Signed informed 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

•1.- Patients that have had a change of PI due to confirmed or suspected virological failure.
•2.- Patients that are taking drugs which its association with Kaletra is contraindicated.
•3.- Active drug adiction or psiquiatric disease that can interfere with the protocol compliance. Cannabis consumption or metadone treatment, as long as it is not interfering with adherence to the protocol according to investigators criteria, is excluded.
•4.- Pregnancy or breastfeeding. In the case of women with childbearing potential, unless thy compromised to the use of an effective contraception method according to investigators criteria, during the whole study.
•5.- If, in oppinion of the investigator, the patient is not likely to follow the protocol or he/she is unacceptable for any other reason.
•6.- Patients with HepB surface antigen positive that are currently receiving treatment with tenofovir or lamivudine.

发起方

H. 12 de Octubre