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

Study Overview
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Brief Summary
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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.

Official Title
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Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211

Conditions
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HIV, HIV Infections

Intervention / Treatment
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* Drug: Vicriviroc maleate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VCV 30 mg<br>Participants take VCV 30 mg once daily. | Drug: Vicriviroc maleate<br>* VCV 30 mg tablet once daily by mouth.<br>* Other names: SCH 417690;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) | 
| 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. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) | 
| 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. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) | 
| 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. | Every 12 months up to 60 months | 
| 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. | Every 12 months up to 60 months | 
| 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. | Every 12 months up to 60 months | 
| 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. | Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years | 
| 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. | Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years | 
| 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. | Up to time of VF in P4100, assessed up to approximately 5.5 years | 
| 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. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) | 
| Number of Participants With New Infections | The number of participants with new infections is reported. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced