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| Sponsors and Collaborators: |
UMC Utrecht Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Erasmus Medical Center Leiden University Medical Center Onze Lieve Vrouwe Gasthuis Slotervaartziekenhuis Rijnstate Hospital Pfizer |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00875368 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 HIV Infections |
Drug: maraviroc Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Maraviroc Immune Recovery Study, A Multicenter, Randomized, Placebo-controlled, Exploratory Mechanistic Study Into the Role of Maraviroc on Immune Recovery |
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Maraviroc: Active Comparator |
Drug: maraviroc
maraviroc dose dependent on co-medication
|
| Placebo: Placebo Comparator | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
And either:
Exclusion Criteria:
Subjects with known hypersensitivity to maraviroc or to peanuts, or any of its excipients or dyes as follows:
Contacts and Locations| Contact: Steven FL van Lelyveld, MD | +31887556228 ext 4553 | s.f.l.vanlelyveld@umcutrecht.nl |
| Contact: Andy IM Hoepelman, MD, PhD | +31887556228 | i.m.hoepelman@umcutrecht.nl |
| Netherlands | |
| Ùniversity Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584CX | |
| Contact: Steven FL van Lelyveld, MD +31887556228 ext 4553 s.f.l.vanlelyveld@umcutrecht.nl | |
| Contact: Andy IM Hoepelman, MD, PhD +31887556228 i.m.hoepelman@umcutrecht.nl | |
| Principal Investigator: Andy IM Hoepelman, MD, PhD | |
| Sub-Investigator: Steven FL van Lelyveld, MD | |
| Rijnstate Hospital | Recruiting |
| Arnhem, Netherlands | |
| Contact: Nienke Langebeek, Msc +3188005 6780 NLangebeek@alysis.nl | |
| Principal Investigator: Clemens Richter, MD | |
| Slotervaartziekenhuis | Not yet recruiting |
| Amsterdam, Netherlands | |
| Contact: J W Mulder, MD +31205129333 jan.mulder@slz.nl | |
| Principal Investigator: Jan W Mulder, MD, PhD | |
| AMC | Not yet recruiting |
| Amsterdam, Netherlands, 1105AZ | |
| Contact: F Lauw, MD, PhD | |
| Principal Investigator: Jan Prins, MD, PhD | |
| Sub-Investigator: Fanny Lauw, MD, PhD | |
| Principal Investigator: | Andy IM Hoepelman, MD, PhD | UMC Utrecht |
More Information
| Responsible Party: | University Medical Center Utrecht ( Prof. Dr. I.M. Hoepelman ) |
| Study ID Numbers: | 08-283 |
| Study First Received: | April 2, 2009 |
| Last Updated: | July 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00875368 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
HIV-1 HAART CD4 cell |
Immunologic non-responders Immunology treatment experienced |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |
