None listed
Conditions
Interventions
Atazanavir plus ritonavir Type of group
Atazanavir, 2 capsules (2 x 200 mg) once a day with food Ritonavir, 1 capsule (100 mg) once a day with food.
Group name:Lopinavir/ritonavir Type of group
Lopinavir / ritonavir 3 capsules (3 x 133.3 lopinavir plus 33.3 ritonavir) once a day with food.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: Virological failure to 2 or more regimens of highly active antiretroviral therapy (HAART) that, in total, included at least one drug of all classes approved protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside transcriptase inhibitors reverse. 16 years old to over. Subjects must be able to provide written informed consent; Subjects must be available for follow-up for a period of at least 48 weeks. Laboratory baseline values were measured within 2 weeks prior to the start of study drugs.
Exclusion criteria
Exclusion criteria: Previous use (> 3 days) of atazanavir, TVF or LPV / RTV; if the history of SQV, then it must be phenotypically sensitive the antiretroviral regimen that fails currently must have been administered for at least eight weeks at the beginning of the screening and should not include both an IP and an NNRTI Presence of a newly diagnosed HIV-related opportunistic infection or any medical treatment that requires acute treatment at the time of enrollment Acute hepatitis proven or suspected within 30 days prior to study entry. Subjects with chronic hepatitis are eligible as long as their liver function enzymes (ALT / AST) are <3 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Mean change of baseline in HIV ribonucleic acid (RNA) at week 24. Mean change from baseline in HIV RNA at week 48. Mean change from baseline in HIV RNA at week 96. Measure:Atazanavir (ATV) in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment in subjects with human immunodeficiency virus (HIV). Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Number of participants with a> 0.5 log10 decrease in HIV RNA from baseline or HIV RNA 0.5 log10 in the HIV RNA from the beginning or HIV RNA 0.5 log10 in HIV RNA from the beginning or HIV RNA <50 c / mL in week 24, due to its initial phenotypic sensitivity to its randomized PI. Measure:Participants achieved the mean suppression of the virological record (LOQ = 50 c / mL) in week 24, by PI Sensitivity Timepoints:24 week | — |
Countries
Peru, United States
Outcome results
None listed