None listed
Conditions
Interventions
Maraviroc Type of group
Maraviroc 300 mg once a day
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Provide your signed and dated informed consent and the assent documents, where appropriate, indicating that the subject (or his legally acceptable representative) has been informed about all relevant aspects of the study; • Be at least 16 years of age (or the minimum adult age, as determined by local regulatory authorities or as established by local law) at the screening visit; • Subjects with limited treatment options or who have no approved treatment option available to them, due to resistance or intolerance; • Subjects who are not obtaining an adequate virological suppression with their current regimen, and who have an HIV-1 RNA level> 1000 copies / ml in the selection or between the Selection visit and the Baseline visit (if it can not be carried out) the determination of the viral load in the Selection); subjects with a viral load in the Selection of <1000 copies / ml who are determined to have the R5 virus by the Trofile assay, may be admitted after discussing the medical history and treatment of the subject with the Pfizer Medical Monitor, and after the subject has signed the complementary informed consent document. • Subjects who have only HIV-1 R5 in the Selection, verified by the Trofile assay of Monogram Biosciences; • Have a negative urine pregnancy test at the baseline visit, before the first dose of study medication, for Women With Potential to Conceive (MPC) only; NOTE: MPCs include any woman who has undergone menarche and who has not undergone effective surgical sterilization, or who is not postmenopausal (that is, no menstrual period for at least 2 years). Even women who are using oral contraceptive, implanted, or hormonal or mechanical injectables (barrier methods, for example, condom or diaphragm with spermicide) to prevent pregnancy, practice abstinence, or whose partner is sterile (eg, vasectomy) , should be considered as women with the potential to conceive; • Agree to use an effective bathtub contraceptive method. In addition, MPCs must use another acceptable method of contraception dm-before the study. Acceptable contraception includes, among others, implanted or injectable hormone therapy; • Be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures; • Subjects that are receiving antiretroviral compounds in research through previously approved expanded access programs or from participation in a phase 3 or 4 clinical study, are eligible to participate in this study, provided that: • 2 agents under investigation to offer the patient a regimen with 2 or 3 active antiretroviral drugs (that is, there are one or fewer approved treatments available to the patient due to resistance or prior intolerance), • None of the protocols prohibits the use of the other agent antiretroviral, AND • The dose of the two agents is known when used together, and a letter from Pfizer´s clinical pharmacologists for Maraviroc identifies the dose of Maraviroc to be used with the other investigational agents.
Exclusion criteria
Exclusion criteria: • Impossibility to provide consent; • Failure of a previous treatment with any CCR5 antagonist, in any ongoing study of CCR5, or that previously have prematurely discontinued the use of Maraviroc in research studies. Subjects currently receiving Maraviroc or another CCR5 antagonist in an ongoing study that is ending or in which the active dose portion of the study in the subjects has ended, may be admitted after discussion with the medical monitor, if: • The subject had only HIV R5 at the time of selection for the other study evaluating the safety and efficacy of Maraviroc or another CCR5 antagonist, and • The subject had achieved a virological response (reduction of> 0.5 log10 with respect to to basal HIV RNA) and never fulfilled the definition of virological failure. • Laboratory abnormality or potentially fatal medical condition (Grade 4) (according to the Division of AIDS table for the classification of the severity of adverse experiences in adults) that is still under investigation, unless an established diagnosis and it is considered that it does not affect the risk / benefit evaluation or the eventual interpretation of the safety results, based on the discussion between the researcher and the medical monitor. • Any condition (including alcohol or drug abuse) that, in the opinion of the investigator, could compromise the subject´s safety or adherence to the study protocol; • Women who are pregnant or breastfeeding, or who plan to become pregnant; • Inability to tolerate oral medication; • Subjects with known hypersensitivity to Maraviroc, peanut or any of its excipients or dyes, as follows: Tablet Excipients: crystalline, crystalline phosphate, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. Film cover: [Opadry II Blue (85G20583)] contains blue aluminum lacquer # 2 FD & C, soy lecithin (soy lecithin), polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of subjects with Grade 3 and 4 Adverse Events (AD) and laboratory abnormalities (in general and according to the causality assigned by the researcher). Measure:Safety Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Determined by the proportion of subjects with a reduction> 0.5 log10 with respect to the baseline in the HIV-I RNA, with a reduction of> 1.0 log10 with respect to the baseline in the HIV-1 RNA, and the proportion of subjects who achieve an HIV-1 RNA value <to the limit of quantification (which will be adjusted to the less sensitive assay used in the study and to the baseline value of the HIV-1 RNA of the subject, if appropriate). Measure:Viral response Timepoints:After treatment ; Outcome name:The change in the CD4 count with respect to the baseline will be determined in the general population. Measure:Change in the CD4 count Timepoints:After treatment ; Outcome name:The appearance / discovery of CXCR4 will be evaluated using the virus between selection (possibly at baseline) and the time of virological failure. Measure:appearance / discovery of CXCR4 Timepoints:During the study ; Outcome name:In subjects who meet the definition of virologic failure during the study, the V3 ring sequence of glycoprotein 120 [gp 120] of the HIV-1 viral envelope and / or the gp 120 whole gene will be evaluated to help to identify any mutation related to a reduction in sensitivity to Maraviroc. Measure:V3 ring sequence of glycoprotein 120 Timepoints:During treatment | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, United Kindgdom
Outcome results
None listed