An International, Multicenter, Prospective Observational Study of the Safety of Maraviroc used with Optimized Background Therapy in Treatment-Experienced HIV-1 Infected Patients
This is an observational, multicenter, open-label, comparative study evaluating the long-term safety of maraviroc (MVC) relative to a non-maraviroc containing regimen. Subjects will be considered eligible for enrollment if their primary HIV providers deem them to be failing their present antiretroviral regimen and consider them candidates for salvage therapeutic agents, which could include a small molecule CCR-5 antagonist such as MVC (MVC is the only agent in this class presently approved for clinical use by the FDA). It is both mandated by the FDA and recommended by HIV practice guidelines that patients being considered for salvage therapy with small-molecule CCR-5 antagonists (MVC being the only such agent approved for use) undergo HIV tropism testing to determine eligibility for use; thus, a tropism assay will also be required as part of the screening visit in this study.
This study will consist of two arms, one composed of 1,500 patients who receive a provider-selected salvage regimen that includes MVC, and one composed of 1,500 patients who receive a provider-selected salvage regimen that does not include MVC. The Medical Monitor assigned to the study will inform all sites as to how many people have been enrolled into each of the arms on a monthly basis. When one of the arms is close to reaching its goal, the Medical Monitor will then inform all sites to please stop screening patients for that particular arm so as not to exceed the goal. The providers will only be allowed to recommend patients for the remaining arm of the study. We anticipate screening 50 patients locally for this study. Patients in the latter arm will consist of those who failed to qualify for MVC either due to tropism criteria or due to provider preference. Any patient who has previously been on the Pfizer A4001050 MVC Expanded Access Study will be allowed to screen for this study, but will not need to have an HIV tropism performed.
Enrollment procedure (Appendix 2 on page 36 of the protocol)
1) Based on history, clinical features and laboratory results, patient[Right Quote]s primary care provider (PCP) considers patient a candidate for salvage therapy, which may include maraviroc.
2) PCP informs patient about the necessity of salvage HIV therapy, which may include maraviroc, invites the patient to participate in the study, and obtains written informed consent.
3) Tropism assay performed, if not done previously.
4) Patients infected with R5-tropic HIV
A) At the discretion of patient[Right Quote]s PCP, patient will either:
1) Be prescribed salvage therapy containing MVC -- and amp;gt; enrolled in MVC-exposed
2) Be prescribed salvage therapy not containing MVC -- and amp;gt; enrolled in MVC non-
5) Patients infected with non-R5 tropic HIV will:
B) Be prescribed salvage therapy not containing MVC -- and amp;gt; enrolled in MVC-non-exposed group
Those subjects that pass all screening procedures and wish to participate will be seen exclusively by their PCP for standard of care monitoring practices throughout study period.
Receive an appropriate HIV-1 tropism assay as a screening for eligibility to receive
maraviroc; Provide signed and dated informed consent to enrolling physician indicating that the
patient (or, legally acceptable representative) has been informed of all pertinent
aspects of the study; Of 18 years of age or older (or, minimum age as determined by local regulatory authorities or as dictated by local law) at the time of enrollment; Provide signed and dated informed consent to allow the enrolling physician access to medical, hospital and vital statistics records as appropriate; Provide information on at least one alternate contact person (preferably the legal next of kin) who can be contacted regarding the patient’s whereabouts and survival status, should the patient be lost-to-follow-up over the course of the study; Acknowledge that in case of his or her death, the next of kin may be approached for a medical records release form if needed; Provide Social Security Number (applicable to U.S. participants) or other national
identification number or national health insurance number, as available and allowed by local law. This information will only be used to search appropriate national or regional cancer and vital status registries for incidences of malignancies and deaths.