Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
HIV Infections, Acquired Immunodeficiency Syndrome
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV Infections, Acquired Immunodeficiency Syndrome, CCR5/CXCR4 mixed tropism, R5/X4 mixed tropism, CCR5 inhibitor, vicriviroc, treatment-experienced
Eligibility 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 of at least 3 months of duration 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. 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 Use of any drugs that predispose to seizures.