Know Cancer

or
forgot password

A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc


Phase 3
16 Years
N/A
Not Enrolling
Both
Advanced HIV Infection

Thank you

Trial Information

A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc


Inclusion Criteria:



- Subjects must be failing to achieve adequate virologic suppression on their current
regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening

- Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay

- Minimum age must be 16 years or minimum adult age as determined by local regulatory
authorities or directed by local law.

Exclusion Criteria:

- Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having
previously prematurely discontinued Maraviroc in trials

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)

Outcome Description:

AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.

Outcome Time Frame:

Baseline up to Week 144

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:

A4001050

NCT ID:

NCT00426660

Start Date:

February 2007

Completion Date:

June 2010

Related Keywords:

  • Advanced HIV Infection
  • HIV Infections
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteBillings, Montana  59101
Pfizer Investigational SiteMorgantown, West Virginia  26506
Pfizer Investigational SiteProvidence, Rhode Island  02906