None listed
Conditions
Interventions
Group 1 Type of group
Atazanavir Next to the 2 current NRTIs (Immediate change group [Day 1])
Group name:Group 2 Type of group
Current ARV regimen (single or enhanced IP with ritonavir plus 2 NRTI (Deferred change group [Week 24]).
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject´s first PI ever received. Plasma HIV-1 RNA level 130 mg/dL.
Exclusion criteria
Exclusion criteria: WOCBP who do not use effective barrier contraception for any reason Women who are pregnant or breast feeding A life expectancy < 12 months Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment Cushing´s Syndrome Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome Untreated hypothyroidism or hyperthyroidism Nephrotic syndrome or significant proteinuria Obstructive liver disease Active alcohol or substance abuse Proven or suspected acute hepatitis in the 30 days prior to study entry Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start History of acute or chronic pancreatitis Inability to swallow capsules Presence of cardiomyopathy Known history of prolonged QTc interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Time to virological rebound (ie, two consecutive measurements of HIV S400 c / ml RNA) in terms of risk ratio for subjects with HIV RNA levels <50 c / ml at the baseline visit. • The magnitude and durability of the increments with respect to the basal value of the absolute CD4 cell count in terms of the difference averaged over time up to week 12. Measure:To compare the average percentage of change in week 12 in fasting LDL cholesterol with respect to the baseline value between subjects receiving a regimen containing atazanavir and those receiving a comparator regimen with PI without atazanavir. Timepoints:week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Average percentage of change with respect to the basal value of total fasting cholesterol, HDL cholesterol, non-HDL cholesterol, apolipoprotein B, and protein triglycerides in week 12. • Mean changes with respect to Ips basal values in fasting glucose and insulin in week 12. • Frequency and severity of all adverse clinical and laboratory events, and interruptions due to adverse events. • Change in quality of life during the 48 weeks that have elapsed since the change to a regimen containing atazanavir. • Change in adherence during the 48 weeks that have elapsed from the time of switching to a regimen containing atazanavir. Measure:To compare the average percentage of change in week 12 in fasting LDL cholesterol with respect to the baseline value between subjects receiving a regimen containing atazanavir and those receiving a comparator regimen with PI without atazanavir. Timepoints:12 week | — |
Countries
Peru, United States
Outcome results
None listed