An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Human Immunodeficiency Virus
Both
Human Immunodeficiency Virus
Trial Information
An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients
All patients meeting the study eligibility criteria at participating sites will be invited
to participate.
Inclusion Criteria:
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths
Outcome Time Frame:
Followed till 6 months after drug discontinuation up to a total of 5 years.
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4001067
NCT ID:
NCT00665561
Start Date:
March 2008
Completion Date:
October 2018
Related Keywords:
- Human Immunodeficiency Virus
- Maraviroc
- HIV-1
- Safety
- Non-interventional
- Acquired Immunodeficiency Syndrome
- HIV Infections
- Immunologic Deficiency Syndromes
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Livingston, New Jersey 07039 |
| Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |
| Pfizer Investigational Site | Morgantown, West Virginia 26506 |
