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TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TMC114 (darunavir) / ritonavir
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, AIDS, TMC114, Protease inhibitor, Darunavir, Antiretroviral agents, Treatment Naive

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with documented HIV-1 infection
  • For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and <100000 copies/mL
  • For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and <500000 copies/mL
  • Patients with CD4+ cell count above 100 cells/µl
  • Patients have voluntarily signed the ICF
  • Patients can comply with the protocol requirements
  • Patient's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

Exclusion Criteria:

  • Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions
  • Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir)
  • Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening
  • Patients with primary HIV infection
  • Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
  • Any active clinically significant disease (e.g., abnormal heart function, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.

    Secondary Outcome Measures

    The secondary objectives are to evaluate safety and tolerability of TMC114/rtv over 48 weeks, to evaluate immunologic response, to evaluate the possible development of resistance and to monitor potential changes in body shape.

    Full Information

    First Posted
    August 6, 2007
    Last Updated
    April 22, 2010
    Sponsor
    Tibotec Pharmaceuticals, Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00513513
    Brief Title
    TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously
    Official Title
    A Phase II, Open Label Trial in Treatment na�ve, HIV 1 Infected Subjects Who Will Receive TMC114/Rtv as a Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Poor recruitment.
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tibotec Pharmaceuticals, Ireland

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients.
    Detailed Description
    This is an open label (no placebo), uncontrolled (all patients will receive TMC114 with ritonavir at the same dose, trial to investigate the sustained anti-viral activity of TMC114/rtv monotherapy in 24 treatment naïve, HIV 1 infected patients over a period of 48 weeks.TMC114, 800 mg daily (2 tablets of 400 mg [F021]) will be given together with 1 capsule (100 mg) of ritonavir.Initially 11 subjects (Panel A, screening viral load between 10000 and 100000 copies/mL) will be included and followed for 8 weeks. If after 8 weeks of dosing at least 7 subjects virologically respond (viral load <400 copies/mL), 13 additional patients (Panel B) will be included. If no virologic failure is observed in at least 18 out of 24 patients who complete 8 weeks of dosing, the trial will continue as planned. In case more than 6 patients in Panel A and Panel B develop a virologic failure after 8 weeks of treatment, the trial will be stopped to conclude the treatment is not effective.The 13 additional patients enrolled in Panel B should have a screening viral load between 20000 and 500000 copies/mL. The CD4+ cell count in all 24 patients should be > 100 cells/µL at screening. The patient's medical condition, adverse events (side effects), study medication compliance, and laboratory evaluations for effectiveness and safety will be assessed at regular intervals. At the end of the 48 weeks treatment period patients will be followed for an additional 4 weeks to evaluate any side effects or laboratory abnormalities. Treatment with TMC114/rtv will be extended for all patients who continue to benefit after 48 weeks. 2 oral tablets of TMC114 400 mg will be administered once daily with 1 capsule (100mg) of ritonavir for 48 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV, AIDS, TMC114, Protease inhibitor, Darunavir, Antiretroviral agents, Treatment Naive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    TMC114 (darunavir) / ritonavir
    Primary Outcome Measure Information:
    Title
    The primary objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.
    Secondary Outcome Measure Information:
    Title
    The secondary objectives are to evaluate safety and tolerability of TMC114/rtv over 48 weeks, to evaluate immunologic response, to evaluate the possible development of resistance and to monitor potential changes in body shape.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with documented HIV-1 infection For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and <100000 copies/mL For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and <500000 copies/mL Patients with CD4+ cell count above 100 cells/µl Patients have voluntarily signed the ICF Patients can comply with the protocol requirements Patient's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. Exclusion Criteria: Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir) Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening Patients with primary HIV infection Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period Any active clinically significant disease (e.g., abnormal heart function, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial.
    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

    Learn more about this trial

    TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously

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