Maraviroc Immune Recovery Study (MIRS):A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery - MIRS

niversitair Medisch Centrum Utrecht0 个研究点开始时间: 2008年7月23日最近更新: 2012年3月19日

试验速览

暂无简介。

•-Age 18 years or older
•-HAART with a maximal treatment interruption of two weeks
•-viral suppression (< 50 copies/ml) for 6 months
•And either:
•-CD+ count < 200 cells/microl after minimal one year of treatment with HAART (study group one)
•-a CD4+ cell count between 200 and 350 cells/microl after minimal two years of treatment with HAART (studygroup two)
•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

•-Previous use of maraviroc
•-HIV-2 infection
•-HAART consisting of a combination of tenofovir and didanosine
•-Active infection for which antimicrobial treatment
•-Acute hepatitis B or C
•-Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirine
•(Note: patients with untreated chronic hepatitis B or C can be included)
•-Immunosuppressive medication
•-Radiotherapy or chemotherapy in the past 2 years
•-Pregnancy or breastfeeding an infant
•-Subjects with known hypersensitivity to Maraviroc or to peanuts, or any of its excipients or dyes as follows:
•Excipiens from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate.
•Film-coat: [Opadry II Blue (85G20583) contains FD&C blue #2 aluminium lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.

发起方

niversitair Medisch Centrum Utrecht