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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003635-20-NL
Enrollment
Unknown
Registered
2008-07-23
Start date
2008-11-18
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection

Interventions

Trade Name: Celsentry Pharmaceutical Form: Coated tablet INN or Proposed INN: maraviroc CAS Number: 376348-65-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Age 18 years or older -HAART with a maximal treatment interruption of two weeks -viral suppression (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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).—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026