Vicriviroc (SCH 417690) in Combination Treatment with Optimized ART Regimen in Experienced Subjects (VICTOR-E2) - VICTOR-E2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001058-26-GB

Enrollment

500

Registered

2005-10-03

Start date

2006-01-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection (mixed X4/R5 torpism) with previous therapy Level: LLT Classification code 10020172

Interventions

Product Name: N/A Product Code: SCH-417690 Pharmaceutical Form: Tablet INN or Proposed INN: vicriviroc Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Adult subjects with documented R5/X4 mixed-tropic HIV infection •Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening •HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen •Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI •Acceptable hematologic, renal and hepatic laboratory parameters Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •No history of recurrent seizure or CNS condition predisposing to seizure •No active AIDS-defining opportunistic infection •Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate antiviral efficacy of vicriviroc compared to placebo in combination with a protease inhibitor (PI)-containing, optimized antiretroviral therapy (ART) regimen in CCR5/CXCR4 (R5/X4) mixed-tropic HIV infected individuals failing a standard three-drug ART regimen.; Secondary Objective: •Time to virologic failure •Percent subjects with <400 copies HIV RNA at 24 and 48 weeks •Percent subjects with <50 copies HIV RNA at 24 and 48 weeks •Mean change from baseline CD4 count at 24 and 48 weeks •Mean change from baseline HIV RNA at 24 and 48 weeks •Incidence of AIDS-defining clinical events •Time to occurrence of AIDS-defining clinical events •Frequency of emergence of viral resistance to vicriviroc •Frequency of emergence of exclusive CXCR4-tropic virus. •Evaluation of PK-PD relationship of vicriviroc through PK-PD population analysis •Frequency of evolution to exclusive CXCR4-tropic virus with concomitant decline in CD4 count by 50% or greater than or equal to 100 cells below baseline. •Description and tabulation of adverse events (AEs), clinically significant laboratory and ECG abnormalities, CNS abnormalities (including seizure), and evaluation of PK-PD relationship of vicriviroc through PK-PD population analysis. ;Primary end point(s): Antiviral efficacy will be based on percentage of patients who achieve a greater than or equal to 1.0 log10 decline from baseline in HIV RNA at 24 weeks.	—

Measure

Time frame

Main Objective: To demonstrate antiviral efficacy of vicriviroc compared to placebo in combination with a protease inhibitor (PI)-containing, optimized antiretroviral therapy (ART) regimen in CCR5/CXCR4 (R5/X4) mixed-tropic HIV infected individuals failing a standard three-drug ART regimen.; Secondary Objective: •Time to virologic failure •Percent subjects with <400 copies HIV RNA at 24 and 48 weeks •Percent subjects with <50 copies HIV RNA at 24 and 48 weeks •Mean change from baseline CD4 count at 24 and 48 weeks •Mean change from baseline HIV RNA at 24 and 48 weeks •Incidence of AIDS-defining clinical events •Time to occurrence of AIDS-defining clinical events •Frequency of emergence of viral resistance to vicriviroc •Frequency of emergence of exclusive CXCR4-tropic virus. •Evaluation of PK-PD relationship of vicriviroc through PK-PD population analysis •Frequency of evolution to exclusive CXCR4-tropic virus with concomitant decline in CD4 count by 50% or greater than or equal to 100 cells below baseline. •Description and tabulation of adverse events (AEs), clinically significant laboratory and ECG abnormalities, CNS abnormalities (including seizure), and evaluation of PK-PD relationship of vicriviroc through PK-PD population analysis. ;Primary end point(s): Antiviral efficacy will be based on percentage of patients who achieve a greater than or equal to 1.0 log10 decline from baseline in HIV RNA at 24 weeks.

—

Countries

Germany, Italy, Portugal, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026