Vicriviroc in Combination Treatment with Optimized ART Regimen in Experienced Subjects (VICTOR-E1) - VICTOR-E1

• Conditions: HIV infection (R5-tropism only) with previous therapy; MedDRA version: 9.1Level: LLTClassification code 10200172

• Registration Number: EUCTR2005-001057-21-DE
• Lead Sponsor: Schering-Plough Research Insititute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult subjects with documented HIV infection with R5-only tropism.
• Prior therapy for at least 3 months with at least 3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening.
• HIV RNA level of at least 1000 copies/mL on a stable ART regimen for at least 6 weeks
• At least 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and at least 1 primary resistance mutation to a PI
• Acceptable hematologic, renal and hepatic laboratory parameters
• QTc internal less than 470 msec (female) and less than 450 msec male

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

• Detectable X4 or R5/X4 virus
• History of recurrent seizure of CNS condition that may predispose the subject to seizure
• Active AIDS defining opportunistic infection
• Prior history of malignancy (with the exceptions of cutaneous Kaposi's sarcoma that resolved with HAART but without systemic anticancer treatment); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy
• Known liver cirrhosis, or clinical symptoms, signs or laboratory abnormalities consistent with cirrhosis

Study & Design

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