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The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
| |
| E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir+Ritonavir+Tenofovir | Drug | Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM. |
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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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| Atazanavir+Ritonavir+Tenofovir+Famotidine | Drug | Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days. |
|
|
| Atazanavir+Ritonavir+Tenofovir+Famotidine | Drug | Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days. |
|
|
| Atazanavir+Ritonavir+Tenofovir+Famotidine | Drug | Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days. |
|
|
| Atazanavir+Ritonavir+Tenofovir+Famotidine | Drug | Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days. |
|
|
| 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 |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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