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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
Open (Enrolling)
Both
Human Immunodeficiency Virus

Thank you

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