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TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
TMC114
Sponsored by
Tibotec Pharmaceuticals, Ireland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, Antiretroviral, TMC114, Ritonavir, Safety, TMC114-C209

Eligibility Criteria

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

Inclusion Criteria: Patient has voluntarily signed the informed consent before initiation of study procedures Patient with documented HIV-1 infection Patient has limited or no treatment options because of multiple treatment failures Negative pregnancy test for females of childbearing potential CD4 cell count < or = 100 cells/mm³ Viral load > or = 10,000 copies/mL. Exclusion Criteria: Primary HIV infection, patient is eligible for other Tibotec-sponsored trials Prior or current participation in a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients) Use of disallowed concomitant therapy Use of investigational medication during the trial or within the last 90 days Female patients who are pregnant or breast feeding or of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial-related activity Patients with previously demonstrated clinically significant allergy or hypersensitivity to any or the excipients of the investigational medication (TMC114) Patients with the laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) table (updated version from December 2004) Any grade 3 or 4 toxicity with the following exceptions: Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4 Patients with asymptomatic triglyceride elevations of grade 3 or 4, patients with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective or liver enzyme levels Note: Patients co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Patients diagnosed with acute viral hepatitis at screening will not be allowed to enroll.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs

    Secondary Outcome Measures

    The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.

    Full Information

    First Posted
    June 20, 2005
    Last Updated
    June 2, 2011
    Sponsor
    Tibotec Pharmaceuticals, Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00115050
    Brief Title
    TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options
    Official Title
    Open-label Safety Study of TMC114 in Combination With Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients With Limited or no Treatment Options.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tibotec Pharmaceuticals, Ireland

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial.
    Detailed Description
    This is an open-label non-randomized safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial. The safety and tolerability of TMC114 in combination with low dose ritonavir (RTV) and other ARVs in highly ARV-experienced HIV-1 infected patients with limited or no treatment options will be assessed. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient. Total daily dose is 600 mg TMC114 twice daily, each intake in combination with one capsule of 100 mg Ritonavir. Since TMC114 is formulated as 300mg tablets (F014) this means 2X2 tablets per day, taken orally. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV infections, Antiretroviral, TMC114, Ritonavir, Safety, TMC114-C209

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    TMC114
    Primary Outcome Measure Information:
    Title
    The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs
    Secondary Outcome Measure Information:
    Title
    The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has voluntarily signed the informed consent before initiation of study procedures Patient with documented HIV-1 infection Patient has limited or no treatment options because of multiple treatment failures Negative pregnancy test for females of childbearing potential CD4 cell count < or = 100 cells/mm³ Viral load > or = 10,000 copies/mL. Exclusion Criteria: Primary HIV infection, patient is eligible for other Tibotec-sponsored trials Prior or current participation in a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients) Use of disallowed concomitant therapy Use of investigational medication during the trial or within the last 90 days Female patients who are pregnant or breast feeding or of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial-related activity Patients with previously demonstrated clinically significant allergy or hypersensitivity to any or the excipients of the investigational medication (TMC114) Patients with the laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) table (updated version from December 2004) Any grade 3 or 4 toxicity with the following exceptions: Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4 Patients with asymptomatic triglyceride elevations of grade 3 or 4, patients with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective or liver enzyme levels Note: Patients co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Patients diagnosed with acute viral hepatitis at screening will not be allowed to enroll.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tibotec Pharmaceuticals Clinical Trial
    Organizational Affiliation
    Tibotec Pharmaceutical Limited
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=985&filename=CR002755_CSR.pdf
    Description
    Clinical Study Report Synopsis of TMC114-C209: A study of safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

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    TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

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