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Maraviroc Compassionate Use

Primary Purpose

Human Immunodeficiency Virus Type 1

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Type 1 focused on measuring Maraviroc Compassionate Use

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
  • Have only CCR5-tropic HIV-1 virus
  • CD4+ cell count < 200 cells/mm3

Exclusion Criteria:

  • CXCR4- or dual/mixed-tropic HIV-1 virus
  • Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness
  • Patients who are pregnant or breast feeding an infant or planning to become pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety analysis will include all subjects who receive at least one dose of study drug

    Secondary Outcome Measures

    Safety analysis will include all subjects who receive at least one dose of study drug

    Full Information

    First Posted
    July 18, 2008
    Last Updated
    May 3, 2016
    Sponsor
    ViiV Healthcare
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00719823
    Brief Title
    Maraviroc Compassionate Use
    Official Title
    Maraviroc Compassionate Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    May 2010 (Anticipated)
    Study Completion Date
    May 2010 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ViiV Healthcare
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.
    Detailed Description
    This study was cancelled prior to enrollment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus Type 1
    Keywords
    Maraviroc Compassionate Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Maraviroc
    Intervention Description
    Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.
    Primary Outcome Measure Information:
    Title
    Safety analysis will include all subjects who receive at least one dose of study drug
    Time Frame
    Two Years
    Secondary Outcome Measure Information:
    Title
    Safety analysis will include all subjects who receive at least one dose of study drug
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen. Have only CCR5-tropic HIV-1 virus CD4+ cell count < 200 cells/mm3 Exclusion Criteria: CXCR4- or dual/mixed-tropic HIV-1 virus Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness Patients who are pregnant or breast feeding an infant or planning to become pregnant.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001068&StudyName=Maraviroc%20Compassionate%20Use
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    Maraviroc Compassionate Use

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