At a glance
ClinicalIndex Comparison Record- ✓Documented HIV infection with no detectable CXCR4-tropic virus (CCR5-tropic only)
- ✓Prior therapy ≥3 months with ≥3 classes of antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors)
- ✓HIV RNA ≥1000 copies/mL on stable ART for ≥6 weeks before screening and ≥8 weeks before randomization
- ✓≥1 documented genotypic RT resistance mutation and ≥1 primary PI resistance mutation
- ✕History of previous malignancy, except cutaneous Kaposi's Sarcoma (without visceral/mucosal involvement, resolved with HAART alone) or surgically resected basal-cell carcinoma
- ✕Treatment with cytotoxic cancer chemotherapy
- ✕Recurrent seizure or CNS condition, or drug use predisposing to seizure
- ✕Active AIDS-defining opportunistic infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1)
In Brief
A Phase 2 clinical trial evaluating Vicriviroc 30 mg, Vicriviroc 20 mg, and 2 other interventions for HIV Infections. Completed, enrolled 116 participants.
Detailed Summary
Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in participants with HIV who have not responded adequately to standard HIV treatments. This study was designed to evaluate the safety and efficacy of doses of vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood. The primary objective of the study was to evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.
Study Details
Timeline
Interventions
Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).
Two tablets of vicriviroc 10 mg once daily for 48 weeks.
Three tablets of placebo once daily for 48 weeks.
Two tablets of placebo once daily for 48 weeks.
An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor \[PI\]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.