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A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

Phase 3
18 Years
Not Enrolling
Acquired Immunodeficiency Syndrome, HIV Infection

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Trial Information

A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

Inclusion Criteria:

- Subjects with limited or no approved treatment options available to them due to
resistance or intolerance;

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

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

Exclusion Criteria:

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

- Potentially life threatening (Grade 4) laboratory abnormality or medical condition
(according to the Division of AIDS table for grading severity of adult adverse
experiences) still under investigation unless a diagnosis has been established and
felt not to affect risk/benefit assessment or eventual interpretation of safety
results, based on discussion between the investigator and Pfizer.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Outcome Description:

AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.

Outcome Time Frame:

Baseline to 30 days post-week 96 or early termination (ET)

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



Brazil: National Ethics Committee (CONEP)

Study ID:




Start Date:

July 2007

Completion Date:

September 2010

Related Keywords:

  • Acquired Immunodeficiency Syndrome
  • HIV Infection
  • Multicenter
  • Open Label
  • Non-Comparative Safety Study Of Maraviroc
  • Treatment Experienced
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes