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

Conditions: HIV-1 infection
MedDRA version: 9.1Level: LLTClassification code 10008919Term: Chronic HIV infection

Registration Number: EUCTR2008-003635-20-NL

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-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)

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

Exclusion Criteria

-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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery.;Secondary Objective: The secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis (see main objective).;Primary end point(s): A 30% increase of the amount CD4+ cells in the treatment group compared with the placebo group (for both study groups).

Secondary Outcome Measures