Maraviroc, a new entry inhibitor, available via expanded access

Maraviroc, a new entry inhibitor, available via expanded access

First watch this cool video that explains how Maraviroc works
http://www.maraviroceap.com/interested_healthcare_professional/ccr5_tropism_video.aspx

Overview and Registration for the Maraviroc EAP

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Overview of the Maraviroc EAP
Welcome to the Maraviroc EAP Website.

Maraviroc is an investigational drug being developed for use in combination with other antiretroviral medications for the treatment of human immunodeficiency virus, type-1 (HIV-1) infected treatment-experienced patients.

Maraviroc uses a new mechanism of action that blocks viral entry into human cells by binding to the chemokine (C-C motif) receptor 5 (CCR5) co-receptor located on the surface of the CD4 cell. It belongs to a new class of drugs known as CCR5 antagonists. The mechanism prevents HIV from entering target cells thereby preventing the initiation of HIV’s replication cycle. This is different from currently available oral HIV/AIDS antiretroviral drugs (such as protease inhibitors, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors) which work by inhibiting HIV/AIDS replication intracellularly. Maraviroc has also been shown in vitro to be effective against HIV/AIDS strains that are resistant to the current classes of HIV/AIDS antiretroviral agents.

Maraviroc, in combination with other antiretrovirals, is currently under development for the treatment of HIV. The trials, MOTIVATE-1 and 2 (Maraviroc Plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced Patients), represent 24-week data of Optimized Background Therapy (OBT), with or without maraviroc, in over 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1.

The purpose of the maraviroc EAP is to provide access to maraviroc for patients who have limited or no other treatment options. This study will also permit collection of safety data in a larger and diverse population. It will also evaluate the effectiveness of maraviroc in treatment-experienced patients who are followed according to local medical practice.

The program has the capacity to enroll up to 6000 men and women worldwide.

Maraviroc EAP Patient Entry Criteria

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Following is a list of some of the major inclusion/exclusion criteria for the maraviroc EAP. Please note that this list is not exhaustive. For further information, please call the Toll Free Line @ 1-888-275-4478 and a clinical research assistant will assist you.
INCLUSION CRITERIA

Subjects, male or female, must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

At least 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law)
Subjects with limited or no approved treatment options available to them due to resistance or intolerance
Have an HIV-1 RNA ≥ 1000 copies/ml
Have only R5 HIV-1
Have negative urine pregnancy test prior to the first dose of study medication for Women of Child Bearing Potential
Agree to use an effective barrier contraception method
Subjects receiving investigational antiretroviral compounds through participation in a Phase 3 or 4 clinical study are eligible to participate in this trial provided:
That the 2 investigational agents are required to offer the patient a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer commercially available agent is available to the patient due to prior resistance or intolerance)
Neither protocol prohibits the use of the other antiretroviral agent, AND
The dosing of the two agents when used together is known AND supported by published literature OR a letter from the Pfizer clinical pharmacologists for maraviroc identifying the dose to be used with maraviroc.
EXCLUSION CRITERIA

Subjects presenting with any of the following will not be included in the trial:

Unable to provide consent
Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
Potentially life threatening (Grade 4) laboratory abnormality or medical condition still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results
Any condition (including alcohol and drug abuse) which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol
Pregnant or nursing an infant, or planning to become pregnant
Inability to tolerate oral medication
Subject requires a contraindicated medication
Subjects with known hypersensitivity to maraviroc, excipients or dyes.
more in Maraviroceap.com

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