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The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Active Comparator |
| |
| A3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir Sulphate | Drug | Capsules, Oral, 200 mg, twice daily, 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID | ||
| Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform |
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Inclusion 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 | Hamilton | New Jersey | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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| Atazanavir Sulphate | Drug | Capsules, Oral, 300 mg, twice daily, 8 days. |
|
|
| Atazanavir Sulphate | Drug | Capsules, Oral, 400 mg, twice daily, 9 days. |
|
|
| Assess the effect of atazanavir BID on metabolic parameters |
| Assess the safety and tolerability of atazanavir when administered BID |
| 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 |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |