HIV infection (R5-tropism only) with previous therapy MedDRA version: 9.1 Level: LLT Classification code 10200172
Conditions
Interventions
Product Name: vicriviroc
Product Code: SCH 417690
Pharmaceutical Form: Tablet
CAS Number: 599179-03-0
Current Sponsor code: SCH 417690
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Schering-Plough Research Insititute, a division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult subjects with documented HIV infection with R5-only tropism. • Prior therapy for at least 3 months with at least 3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening. • HIV RNA level of at least 1000 copies/mL on a stable ART regimen for at least 6 weeks • At least 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and at least 1 primary resistance mutation to a PI • Acceptable hematologic, renal and hepatic laboratory parameters • QTc internal less than 470 msec (female) and less than 450 msec male Are the trial subjects under 18? no 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: • Detectable X4 or R5/X4 virus • History of recurrent seizure of CNS condition that may predispose the subject to seizure • Active AIDS defining opportunistic infection • Prior history of malignancy (with the exceptions of cutaneous Kaposi's sarcoma that resolved with HAART but without systemic anticancer treatment); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy • Known liver cirrhosis, or clinical symptoms, signs or laboratory abnormalities consistent with cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate antiviral efficacy of 2 doses of vicriviroc maleate compared to placebo in combination with a ritonavir-boosted protease inhibitor (PI) containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.;Secondary Objective: • To evaluate the dose–response relationship of the two dosages of vicriviroc maleate along with an optimized background ART regimen. • To evaluate the pharmacokinetic–pharmacodynamic (PK–PD) relationship of vicriviroc maleate through the use of PK–PD population analyses. • To evaluate clinical efficacy with respect to the following: • Time to occurrence of AIDS-defining clinical events. • Incidence of AIDS-defining clinical events. • Frequency of emergence of viral resistance to vicriviroc • Frequency of emergence of CXCR4-tropic virus • Frequency of emergence of CXCR4-tropic virus with concomitant decline in CD4 count by more than or equal to 50% below baseline • Frequencies of AEs and clinically significant abnormalities in ECGs, laboratory findings, or CNS findings. ;Primary end point(s): The primary endpoint for the study is the log10 change from baseline in HIV RNA at 48 weeks. Key secondary endpoints are: Proportion of subjects with at least a 1.0 log10 change from baseline HIV RNA at 48 weeks Proportion of subjects with HIV RNA <400 copies/mL at 48 weeks Time to virologic failure, defined as the time from randomization to either: - failure to experience HIV RNA decline of at least 0.5 log10 at 4 weeks after baseline, in which case time will be set to 0, OR - rebound of HIV RNA to within 0.5 log10 of baseline at any time after maximal suppression Either event of virologic failure must be confirmed on a repeat test | — |
Countries
Germany, Italy, Portugal, United Kingdom
Outcome results
None listed