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Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5)

Primary Purpose

HIV Infections, Acquired Immunodeficiency Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vicriviroc
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Treatment Experienced

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must be infected with HIV-1 virus.

  • Subject must have documented plasma HIV-1 RNA >1000 copies/mL within 60 days of Visit 1/Day 1 (randomization) and must be either

    • on a stable regimen of 3 or more antiretrovirals (ART) for at least 4

weeks prior to the screening visit

OR

  • on no ART agents for at least 4 weeks prior to

the screening visit.

  • Subject must be ART experienced and have documented resistance to at least 2 of the following 3 drug classes: nucleoside reverse transcriptase inhibitor (NRTI); non-nucleoside reverse transcriptase inhibitor (NNRTI); or protease inhibitor (PI)

OR

Subject must have ART class experience for at least 6 months with at least two of the following: one NRTI; one NNRTI; two PIs (excluding low-dose ritonavir).

  • Women of child-bearing potential must agree to use a medically accepted method of contraceptive as defined by the protocol.
  • Subject must be willing to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infection as defined in protocol.

Exclusion Criteria:

  • Subjects with detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening.
  • Subjects with prior history of malignancy (with exceptions of cutaneous Kaposi's sarcoma without visceral or mucosal involvement that resolved with HAART but without systemic anti-cancer treatment, and basal-cell carcinoma of skin); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy.
  • Subjects with seizure disorder requiring anti-seizure therapy or with any condition that is likely to increase risk of seizure (CNS malignancy or toxoplasmosis).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Test Arm

    Placebo Control Arm

    Arm Description

    Vicriviroc 30 mg QD

    Placebo

    Outcomes

    Primary Outcome Measures

    Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL)

    Secondary Outcome Measures

    Mean change from baseline in plasma HIV-1 RNA (log10 copies/mL); Proportion of subjects with <400 copies/mL of plasma HIV-1 RNA; Proportion of subjects with >=2log10 reduction from baseline in plasma HIV-1 RNA

    Full Information

    First Posted
    August 30, 2007
    Last Updated
    September 24, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00523211
    Brief Title
    Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5)
    Official Title
    Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E3)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated.
    Detailed Description
    This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects infected with CCR5-tropic virus only and who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or PI) or at least 6 months experience with at least 2 of the following: one NRTI, one NNRTI, or two PIs (excluding low-dose ritonavir)and failed at least one standard triple-drug regimen. The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening, history of prior antiretroviral drug use by the patient, and drug toxicity. OBT must include a PI boosted by ritonavir (>=100 mg ritonavir), and at least 2 active drugs (ie, to which HIV isolate is fully susceptible). Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. An interim analysis will be performed when all subjects have completed 24 weeks of treatment. After completing Week 48 of the study, subjects who meet applicable criteria will be offered open-label vicriviroc 30 mg QD, if appropriate until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    506 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Arm
    Arm Type
    Experimental
    Arm Description
    Vicriviroc 30 mg QD
    Arm Title
    Placebo Control Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Vicriviroc
    Other Intervention Name(s)
    SCH 417690
    Intervention Description
    One tablet of vicriviroc 30 mg once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    One tablet of placebo once daily.
    Primary Outcome Measure Information:
    Title
    Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL)
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    Mean change from baseline in plasma HIV-1 RNA (log10 copies/mL); Proportion of subjects with <400 copies/mL of plasma HIV-1 RNA; Proportion of subjects with >=2log10 reduction from baseline in plasma HIV-1 RNA
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be infected with HIV-1 virus. Subject must have documented plasma HIV-1 RNA >1000 copies/mL within 60 days of Visit 1/Day 1 (randomization) and must be either on a stable regimen of 3 or more antiretrovirals (ART) for at least 4 weeks prior to the screening visit OR on no ART agents for at least 4 weeks prior to the screening visit. Subject must be ART experienced and have documented resistance to at least 2 of the following 3 drug classes: nucleoside reverse transcriptase inhibitor (NRTI); non-nucleoside reverse transcriptase inhibitor (NNRTI); or protease inhibitor (PI) OR Subject must have ART class experience for at least 6 months with at least two of the following: one NRTI; one NNRTI; two PIs (excluding low-dose ritonavir). Women of child-bearing potential must agree to use a medically accepted method of contraceptive as defined by the protocol. Subject must be willing to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infection as defined in protocol. Exclusion Criteria: Subjects with detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening. Subjects with prior history of malignancy (with exceptions of cutaneous Kaposi's sarcoma without visceral or mucosal involvement that resolved with HAART but without systemic anti-cancer treatment, and basal-cell carcinoma of skin); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy. Subjects with seizure disorder requiring anti-seizure therapy or with any condition that is likely to increase risk of seizure (CNS malignancy or toxoplasmosis).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22634184
    Citation
    Caseiro MM, Nelson M, Diaz RS, Gathe J, de Andrade Neto JL, Slim J, Solano A, Netto EM, Mak C, Shen J, Greaves W, Dunkle LM, Vilchez RA, Zeinecker J. Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: final results of two randomized phase III trials. J Infect. 2012 Oct;65(4):326-35. doi: 10.1016/j.jinf.2012.05.008. Epub 2012 May 24.
    Results Reference
    derived

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    Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5)

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