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The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanvir/ritonavir + efavirenz | Drug | Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from baseline in fasting plasma triglycerides at Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48 | ||
| The mean percent change from baseline in fasting plasma triglycerides at Wk 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 | San Francisco | California | United States | |||
| Local Institution |
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| Atazanvir/ritonavir + efavirenz | Drug | Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks. |
|
|
| Washington D.C. |
| District of Columbia |
| United States |
| Local Institution | Atlantis | Florida | United States |
| Local Institution | Orlando | Florida | United States |
| Local Institution | South Miami | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Boston | Massachusetts | United States |
| Local Institution | Berkley | Michigan | United States |
| Local Institution | St Louis | Missouri | United States |
| Local Institution | Huntersville | North Carolina | United States |
| Local Institution | Clumbia | South Carolina | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Hampton | Virginia | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| C098320 | efavirenz |
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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