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Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

Primary Purpose

HIV Infections

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
raltegravir
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for HIV Infections

Eligibility Criteria

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

Inclusion Criteria:

  • HIV positive patients who have limited or no treatment options and have documented resistance

Exclusion Criteria:

  • Patient has previously been on MK0518 therapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2006
    Last Updated
    April 21, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00377065
    Brief Title
    Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)
    Official Title
    Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    raltegravir
    Other Intervention Name(s)
    MK0518, ISENTRESS™
    Intervention Description
    raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV positive patients who have limited or no treatment options and have documented resistance Exclusion Criteria: Patient has previously been on MK0518 therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

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