Maraviroc Immune Recovery Study (MIRS)
|ClinicalTrials.gov Identifier: NCT00875368|
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : September 10, 2013
Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A certain group of patients, the so called "immunologic non responders", fail to reach an acceptable CD4 cell increase despite an adequate virologic response on antiretroviral treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic response. This suggests an alternative mechanism for immune recovery, which could be especially beneficial for this group of patients.
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:
- In the treatment group subjects will start with a registered antiretroviral agent (maraviroc).
- During the treatment year patients will perform several study visits, probably three more compared with regular visits on the outpatient clinic.
- Each visit, blood will be drawn by venepuncture for immunologic and virologic investigations (see flow chart).
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: maraviroc Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||August 2012|
|Active Comparator: Maraviroc||
maraviroc dose dependent on co-medication
Placebo Comparator: Placebo
- 30% increase in CD4+ cell count after 48 weeks [ Time Frame: 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875368
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 AC|
|Academisch Medisch Centrum (AMC)|
|Amsterdam, Netherlands, 1105AZ|
|Leids Universitair Medisch Centrum (LUMC)|
|Rotterdam, Netherlands, 3015GJ|
|Sint Elisabeth Ziekenhuis|
|Ùniversity Medical Center Utrecht|
|Utrecht, Netherlands, 3584CX|
|Principal Investigator:||Andy IM Hoepelman, MD, PhD||UMC Utrecht|