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Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vicriviroc maleate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Treatment Experienced

Eligibility Criteria

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

Inclusion Criteria:

  • Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
  • Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
  • Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.

Exclusion Criteria:

  • History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
  • Female participants who are breast-feeding, pregnant, or plan to become pregnant
  • Participation in a clinical trial with another investigational drug.
  • Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    VCV 30 mg

    Arm Description

    Participants take VCV 30 mg once daily.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With ≥1 Adverse Events (AEs)
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
    Percentage of Participants Discontinuing Study Therapy Due to AEs
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
    Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
    An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
    Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
    The percentage of participants with HIV RNA <50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Percentage of Participants With HIV RNA >50 to <400 Copies/mL
    The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Percentage of Participants With HIV RNA ≥400 Copies/mL
    The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Number of Participants With Coreceptor Tropism Shifts From Baseline
    The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
    Mean Change From Baseline in CD4/CD8 Cell Counts
    The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
    Number of Participants With Reduced Susceptibility to VCV
    The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
    Number of Participants With AIDS-defining Events (ADEs)
    The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
    Number of Participants With New Infections
    The number of participants with new infections is reported.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2008
    Last Updated
    December 2, 2020
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00686829
    Brief Title
    Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
    Official Title
    Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2005 (Actual)
    Primary Completion Date
    October 21, 2010 (Actual)
    Study Completion Date
    October 21, 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    79 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VCV 30 mg
    Arm Type
    Experimental
    Arm Description
    Participants take VCV 30 mg once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Vicriviroc maleate
    Other Intervention Name(s)
    SCH 417690
    Intervention Description
    VCV 30 mg tablet once daily by mouth.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With ≥1 Adverse Events (AEs)
    Description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
    Time Frame
    Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
    Title
    Percentage of Participants Discontinuing Study Therapy Due to AEs
    Description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
    Time Frame
    Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
    Title
    Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
    Description
    An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
    Time Frame
    Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
    Title
    Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
    Description
    The percentage of participants with HIV RNA <50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Time Frame
    Every 12 months up to 60 months
    Title
    Percentage of Participants With HIV RNA >50 to <400 Copies/mL
    Description
    The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Time Frame
    Every 12 months up to 60 months
    Title
    Percentage of Participants With HIV RNA ≥400 Copies/mL
    Description
    The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
    Time Frame
    Every 12 months up to 60 months
    Title
    Number of Participants With Coreceptor Tropism Shifts From Baseline
    Description
    The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
    Time Frame
    Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
    Title
    Mean Change From Baseline in CD4/CD8 Cell Counts
    Description
    The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
    Time Frame
    Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
    Title
    Number of Participants With Reduced Susceptibility to VCV
    Description
    The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
    Time Frame
    Up to time of VF in P4100, assessed up to approximately 5.5 years
    Title
    Number of Participants With AIDS-defining Events (ADEs)
    Description
    The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
    Time Frame
    Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
    Title
    Number of Participants With New Infections
    Description
    The number of participants with new infections is reported.
    Time Frame
    Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure. Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters. Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing. Exclusion Criteria: History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements Female participants who are breast-feeding, pregnant, or plan to become pregnant Participation in a clinical trial with another investigational drug. Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    20672447
    Citation
    Wilkin TJ, Su Z, Krambrink A, Long J, Greaves W, Gross R, Hughes MD, Flexner C, Skolnik PR, Coakley E, Godfrey C, Hirsch M, Kuritzkes DR, Gulick RM. Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2010 Aug;54(5):470-6. doi: 10.1097/qai.0b013e3181e2cba0.
    Results Reference
    result
    PubMed Identifier
    20400411
    Citation
    Yeh TM, Evans SR, Gulick RM, Clifford DB. Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211. HIV Clin Trials. 2010 Jan-Feb;11(1):51-8. doi: 10.1310/hct1101-51.
    Results Reference
    result
    PubMed Identifier
    19191652
    Citation
    Tsibris AM, Paredes R, Chadburn A, Su Z, Henrich TJ, Krambrink A, Hughes MD, Aberg JA, Currier JS, Tashima K, Godfrey C, Greaves W, Flexner C, Skolnik PR, Wilkin TJ, Gulick RM, Kuritzkes DR. Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis. 2009 Mar 1;48(5):642-9. doi: 10.1086/597007.
    Results Reference
    result

    Learn more about this trial

    Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)

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