Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Vicriviroc 30 mg; Vicriviroc 20 mg; Placebo; Placebo; Background ART Regimen
Intervention description: Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).; Two tablets of vicriviroc 10 mg once daily for 48 weeks.; Three tablets of placebo once daily for 48 weeks.; Two tablets of placebo once daily for 48 weeks.; An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: There were Double-blind and an Open Label extension period.
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of
      drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs
      blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that
      fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of
      vicriviroc in participants with HIV who have not responded adequately to standard HIV
      treatments. This study was designed to evaluate the safety and efficacy of doses of
      vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease
      the level of HIV (viral load) in the blood. The primary objective of the study was to
      evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in
      combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART)
      regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants with documented HIV infection with no detectable C-X-C Motif
             Chemokine Receptor 4 (CXCR4)

          -  Prior therapy for ≥3 months with ≥3 classes of currently marketed (US FDA-approved)
             antiretroviral agents (nucleoside reverse transcriptase inhibitor, NRTIs,
             non-nucleoside reverse transcriptase inhibitor (NNRTIs), protease inhibitor (PIs), or
             fusion inhibitors) at any time prior to screening

          -  HIV ribonucleic acid (RNA) ≥1000 copies/mL on a stable ART regimen for ≥6 weeks prior
             to Screening and ≥8 weeks prior to randomization

          -  ≥1 genotypically documented resistance mutation to a reverse transcriptase (RT)
             inhibitor and ≥1 primary resistance mutation to a PI

          -  Acceptable hematologic, renal and hepatic laboratory parameters

        Exclusion Criteria:

          -  No history of previous malignancy (with the exceptions of cutaneous Kaposi's Sarcoma
             without visceral or mucosal involvement that resolved with highly active
             antiretroviral therapy (HAART) but without systemic anti-cancer treatment, and
             basal-cell carcinoma of skin surgically resected with disease-free margins on
             pathology exam)

          -  Treatment with cytotoxic cancer chemotherapy,

          -  Recurrent seizure, or central nervous system (CNS) condition or drug use predisposing
             to seizure in the opinion of the investigator

          -  No active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection