A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-004306-50-AT
• Date of registration: 21/05/2007
• Prospective Registration: No
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC
• Scientific title: A MULTI-CENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC
• Date of first enrolment: 24/04/2007
• Target sample size: 6000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004306-50
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

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

1.Provide signed and dated informed consent and assent documents where applicable indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial;
2.At least 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at screening visit;
3.Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
4.Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA = 1000 copies/ml, at screening;
5.Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay;
6.Have negative urine pregnancy test at the baseline visit, prior to the first dose of study medication for Women of Child Bearing Potential (WOCBP) only; NOTE: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal (i.e., no menstrual periods for at least 2 years). Even women who are using oral, implanted or injectable contraceptive hormone or mechanical products (barrier methods; e.g., condom or diaphragm with spermicide) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (e.g., vasectomy), should be considered to be of child bearing potential;
7.Agree to use an effective barrier contraception method. In addition, WOCBP must use another acceptable method of contraception for the duration of the study. Acceptable contraception includes, but is not limited to, oral, implanted or injectable hormone therapy;
8.Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedure
9. Subjects receiving investigational antiretroviral compounds through pre-approval expanded access programs or 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 approved treatment 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 OR a letter from
the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc
to be used with other the investigational agents.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the trial:
1.Unable to provide consent;
2. Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued maraviroc in trials. Subjects who are currently receiving maraviroc or other CCR5 antagonist in an ongoing trial which is being terminated or the subjectsactive dosing portion of the trial is completed, may be enrolled after discussion with the medical monitor if:
• The subject had only R5 HIV at time of screening for the other study evaluating the
safety and efficacy of maraviroc or another CCR5 antagonist AND
• The subject had achieved a virologic response (= 0.5 log10 copies/ml reduction from
baseline HIV RNA) and never met the definition of virologic failure.
3.Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and medical monitor.
4.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;
5.Pregnant or breast feeding an infant, or planning to become pregnant;
6.Inability to tolerate oral medication;
7.Subject requires a contraindicated medication;
OR
8.Subjects with known hypersensitivity to maraviroc 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 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV
MedDRA version: 8.1 Level: LLT Classification code 10020192 Term: HIV-1

Intervention(s)

Product Name: Maraviroc
Product Code: UK-427,857
Pharmaceutical Form: Tablet
CAS Number: 376348-65-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: The primary objective of the maraviroc expanded access program is to facilitate access to maraviroc for subjects, who have limited therapeutic options and to collect safety data in a larger and more diverse patient population than that which participated in the phase 2/3 clinical trials.

Secondary Objective: The secondary objective of the maraviroc expanded access program is to evaluate the effectiveness of maraviroc in treatment-experienced patients who are followed according to local medical practice.

Primary end point(s): The Primary endpoint of this study is safety

Secondary ID(s)

2006-004306-50-IE

A4001050