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

Phase 1

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

• Registration Number: EUCTR2005-001058-26-PT
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-09
• Study Completion: 2006-01-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified