Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4). - VICTOR E4

• Conditions: HIV infection (R5 tropism only) with previous therapy; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-006417-32-IT
• Lead Sponsor: Schering Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

1) Subjects must be at least 16 years of age (or minimum age as determined by local regulatory authorities at time of randomization, of either sex, and of any race 2) Subjects must be infected with HIV-1 virus as documented by a positive assay for HIV-1 RNA in plasma 3) Subjects must have plasma HIV-1 RNA >1000 copies/mL within 60 days of randomization either on a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at time of screening or not on any antiretroviral agents for greater than or equal to 4 weeks prior to screening 4) Subjects must be ART-experienced and have documented resistance to at least 2 of the following 3 drug classes: NRTI, NNRTI or PI or antiretroviral class experience for at least 6 months with each of the drug classes mentioned.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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

1) Subjects must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening (i.e. HIV isolate must be solely CCR5-tropic) 2) Subjects must not have any condition that, in the opinion of the investigator, is likely to increase the risk of seizures 3) Subjects must not have a prior history of malignancy (with the exceptions of surgically resected basal-cell carcinoma or cutaneous Kaposi's sarcoma without visceral or mucosal inlvolement that resolved without systemic anticancer treatment).

Study & Design

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