HIV infection (R5 tropism only) with previous therapy MedDRA version: 9.1 Level: LLT Classification code 10200172 Term:
Conditions
Interventions
Product Name: Vicriviroc (SCH 417690) maleate tablets
Product Code: SCH 417690 maleate
Pharmaceutical Form: Tablet
INN or Proposed INN: Vicriviroc
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the hypothesis that vicriviroc 30 mg QD provides added benefit in plasma HIV-1 RNA reduction when added to optimized background therapy (OBT), as measured by the proportion of subjects with HIV RNA <50 copies/mL at Week 48.;Secondary Objective: To evaluate the safety and tolerability of vicriviroc compared to placebo, each in combination with OBT.;Primary end point(s): Proportions of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL by Ultrasensitive Amplicor HIV-1 Monitor Test, version 1.5) at 48 weeks will be compared to between vicriviroc and control groups as the primary measure of antiviral efficacy. Proportion of subjects with clinically significant laboratory abnormalities (ie, abnormalities requiring medical intervention). | — |
Countries
France, Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed