A Phase 3 interventional study of atazanavir/ritonavir +2 NRTIs (immediate Switch Group) and LPV/r +2 NRTIs (Delayed/optional Switch Group) in HIV Infections, sponsored by Bristol-Myers Squibb. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-05.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 192 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.
Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.
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Exclusion Criteria:
Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)
Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)
Drug page: Atazanavir
Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
Also known as: Reyataz
Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
The record gives a start of Jan 2004, a primary completion of May 2006 and a completion of May 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atazanavir