None listed
Conditions
Interventions
active comparator I Type of group
ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV, RTV and TDF once a day, nucleoside by label 48 weeks and then while the subject needs therapy through the study.
Group name:ACTIVE COMPORATOR Type of group
LPV / RTV 400/100 mg + TDF 300 mg + nucleoside of choice. LPV / RTV twice a day, TDF once a day, nucleoside by label 48 weeks and then while the subject needs therapy through the study
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: The patients must have HIV infection, have not responded to 2 or more previous antiretroviral treatments that in total must have included medicines of all approved classes (IP, INNTI, INTI), have a plasma HIV RNA load of> 1,000 c / mL (Roche Amplicor®) and a CD4 cell count of> 50 cells / mm3.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they have previously used (> 30 days) atazanavir, SQV, TFV or lopinavir / ritonavir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 [ Time Frame: Baseline, Week 24 ] 2) Mean Change From Baseline in HIV RNA at Week 48 [ Time Frame: Baseline, Week 48 ] 3) Mean Change From Baseline in HIV RNA at Week 96 [ Time Frame: Baseline, Week 96 ] Measure:Treatment regimens with atazanavir with the lopinavir / RTV treatment regimen with respect to the magnitude of reduction of plasma HIV RNA from the baseline. Timepoints:each 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Mean Change From Baseline in HIV RNA at Week 2 [ Time Frame: Baseline, Week 2 ] 2) Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) [ Time Frame: Baseline, Week 24 ] Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA 0.5 log10 reduction in HIV RNA relative to the baseline, or an HIV RNA level of =0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI. Measure:Proportion of subjects with HIV RNA levels < LDC (LDC = 400 c / mL and LDC = 50 c / mL) at Weeks 24 and 48. Timepoints:week 24 | — |
Countries
Canada, Mexico, Peru, United States
Outcome results
None listed