None listed
Conditions
Interventions
Group 1 Type of group
Vicriviroc tablet 30 mg, administered orally, once a day for 48 weeks
Group name:Group 2 Type of group
Similar placebo tablet administered orally, once a day for 48 weeks
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • The subject must be at least 16 years of age (or the minimum age determined by the local regulatory authorities) at the time of randomization and be of any sex and age. • The subject must be infected with the HIV-1 virus, confined by a positive analysis of HIV-1 RNA in plasma, prior to the selection stage. • The subject must submit> 1000 copies / ml of HIV-1 RNA in plasma within 60 days prior to randomization, either: a. with a stable regimen of 3 or more antiretroviral agents for at least 4 weeks at the time of selection. b. without treatment with antiretroviral agents, for> 4 weeks before the Selection. • Subjects must have received ART and have confirmed resistance (determined by the HIV Monogram GeneSEq or PhenoSense drug resistance assay) to at least 2 of the following 3 classes of drugs; NRTI, NNRTI or IP OR have been treated for at least 6 months (consecutive or cumulative) with each of the following classes: NRTI, NNRTI, IP.
Exclusion criteria
Exclusion criteria: • Subjects should not present tropic HIV strains to CXCR4 or dual / mixed tropism CCR5 / CXCR4 in the Selection stage (ie, that the HIV strain should only be tropic to CCR5). • Subjects must not present any condition that, in the opinion of the investigator, may increase the risk of seizures. • Subjects should not have a history of cancer (with the exception of surgically excised basal cell carcinoma or Kaposi´s sarcoma without visceral or mucosal involvement that would have resolved without systemic antineoplastic therapy).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HIV-1 RNA in plasma Measure:The mean change in the baseline value of HIV-1 RNA in plasma (logio copies / ml) at 48 weeks Timepoints:48 weeks ; Outcome name:Measurement of HIV-1 RNA in plasma Measure:The proportion of subjects with 2 log10 of the baseline value of HIV-1 RNA at 48 weeks. Timepoints:48 weeks ; Outcome name:Time to loss of a virological response (TLOVR) Measure:Time to loss of a virological response (TLOVR) Timepoints:48 weeks ; Outcome name:CD4 + count Measure:The average change of the CD4 + count with respect to the start. Timepoints:48 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportions of subjects with undetectable plasma HIV-1 RNA at the 48 weeks Measure:Proportions of subjects with undetectable plasma HIV-1 RNA at the 48 weeks Timepoints:48 weeks | — |
Contacts
Public ContactALFREDO PAREDES
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed