Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.; Schering-Plough

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.