Maraviroc Immune Recovery Study (MIRS): A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery
- Conditions
- 10047438HIVhuman immunodeficiency virus
- Registration Number
- NL-OMON35447
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A 30% increase in CD4 cell rise in the treatment group (compared with placebo).</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable.</p><br>