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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1 | Active Comparator |
| |
| G2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atazanavir/ritonavir +2 NRTIs (immediate Switch Group) | Drug | Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Phoenix | Arizona | United States | |||
| Local Institution |
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| LPV/r +2 NRTIs (Delayed/optional Switch Group) | Drug | Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks. |
|
| 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. |
| Bakersfield |
| California |
| United States |
| Local Institution | Los Angeles | California | United States |
| Local Institution | San Francisco | California | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Columbia | South Carolina | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Hamilton | Ontario | Canada |
| Local Institution | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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