Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2009-02-28
2012-08-31
Brief Summary
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Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing CD4+ cell count.
Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates immune recovery; the secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.
Study design: multicentre, randomized, placebo-controlled, double blind, exploratory mechanistic study.
Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria.
Intervention: One group receives maraviroc (dose dependent on co-medication), the other group placebo.
Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group (compared with placebo).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
1. In the treatment group subjects will start with a registered antiretroviral agent (maraviroc).
2. During the treatment year patients will perform several study visits, probably three more compared with regular visits on the outpatient clinic.
3. Each visit, blood will be drawn by venepuncture for immunologic and virologic investigations (see flow chart).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Maraviroc
maraviroc
maraviroc dose dependent on co-medication
Placebo
Placebo drug
Placebo
Placebo drug
Interventions
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maraviroc
maraviroc dose dependent on co-medication
Placebo
Placebo drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HAART with a maximal treatment interruption of two weeks
* viral suppression (\< 50 copies/ml) for 6 months
* And either:
* CD4+ count \< 200 cells/microliter after minimal one year of treatment with HAART (study group one) OR
* a CD4+ cell count between 200 and 350 cells/microliter after minimal two years of treatment with HAART (study group two)
Exclusion Criteria
* Active infection for which antimicrobial treatment
* Acute hepatitis B or C
* Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirin (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:
* Excipients 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.
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Erasmus Medical Center
OTHER
Leiden University Medical Center
OTHER
Onze Lieve Vrouwe Gasthuis
OTHER
Slotervaart Hospital
OTHER
Rijnstate Hospital
OTHER
Pfizer
INDUSTRY
S.F.L. van Lelyveld
OTHER
Responsible Party
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S.F.L. van Lelyveld
Coordinating investigator
Principal Investigators
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Andy IM Hoepelman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Slotervaartziekenhuis
Amsterdam, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Kennemer Gasthuis
Haarlem, , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Sint Elisabeth Ziekenhuis
Tilburg, , Netherlands
Ùniversity Medical Center Utrecht
Utrecht, , Netherlands
Countries
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References
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van Lelyveld SF, Drylewicz J, Krikke M, Veel EM, Otto SA, Richter C, Soetekouw R, Prins JM, Brinkman K, Mulder JW, Kroon F, Middel A, Symons J, Wensing AM, Nijhuis M, Borghans JA, Tesselaar K, Hoepelman AI; MIRS study group. Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial. PLoS One. 2015 Jul 24;10(7):e0132430. doi: 10.1371/journal.pone.0132430. eCollection 2015.
Other Identifiers
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08-283
Identifier Type: -
Identifier Source: org_study_id