E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maraviroc (UK 427,857) is an investigational medication, being developed for use in combination with other antiretroviral medications, for the treatment of treatment-experienced patients infected with CCR5-tropic human immunodeficiency virus, type-1 (HIV-1). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the maraviroc expanded access program is to facilitate access to maraviroc for patients, 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. |
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E.2.2 | Secondary objectives of the trial |
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 in more than 30 countries throughout the world. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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: ユ 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), ユ Neither protocol prohibits the use of the other antiretroviral agent, ANDユ The dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with the other investigational agents. |
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E.4 | Principal exclusion criteria |
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 subjects active dosing portion of the trial is completed, may be enrolled after discussion with the medical monitor if: ユ 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 ユ The subject had achieved a virologic response (> 0.5 log10 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メ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 (see section 5.4 Concomitant Medication); OR 8. Subjects with known hypersensitivity to maraviroc or any of its excipients or dyes as follows: ユ Excipients from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. ユ 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is safety. For a list of planned analyses, see Section 7.1 Safety Assessments and Section 9.2.1 Statistical Analysis, Analysis of Primary Endpoint. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |