Pzifer Poem Study: AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The objective of this international, multicenter, prospective observational comparative study is to monitor the safety of long term use of maraviroc in a larger and more diverse patient population than that in which the Phase 2b/3 clinical trials were conducted. By providing additional data regarding long-term use of maraviroc, this study will help further characterize the safety profile of the drug.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Maraviroc
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Receive an appropriate HIV-1 tropism assay as a screening for eligibility to receive maraviroc;
2. 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;
3. 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;
4. Provide signed and dated informed consent to allow the enrolling physician access to medical, hospital and vital statistics records as appropriate;
5. 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;
6. Acknowledge that in case of his or her death, the next of kin may be approached for a medical records release form if needed;
7. 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.
Key Exclusion Criteria:
1. Pregnant or lactating.
2. Unable to provide informed consent.
3. Recipient of a small molecule CCR5 inhibitor other than maraviroc.
4. Previously enrolled in this study.
Additional Study Details
Official Title:
AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTSAnticipated start date:
2/5/2009Lead Sponsor:
PfizerInvestigator(s):
- Andrew R Zolopa
- Michael J. Harbour
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
LongitudinalSelection:
Defined PopulationTiming:
ProspectiveTotal Number to be Enrolled:
2000Total Number to be Enrolled at Stanford:
10More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
1/28/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help
Administrator Login