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 个研究点目标入组 130 人开始时间: 待定最近更新: 2024年5月6日

适应症

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);Or:
•-a CD4+ cell count between 200 and 350 cells/microl after minimal two years of treatment with HAART (studygroup two)

•-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