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The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | No Intervention |
| |
| A2 | Experimental |
| |
| A3 | Experimental |
| |
| B1 | No Intervention |
| |
| B2 | Experimental |
| |
| B3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir/Ritonavir | Drug | Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atazanavir plasma drug concentrations | on days 10, 11, 17, 18, 24 and 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Ritonavir plasma drug concentrations | on days 10, 11, 17, 18, 24 and 25 | |
| Safety measures: Physical examinations | ||
| ECGs |
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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 |
|---|---|---|---|---|---|---|
| Garden State Infectious Disease Associates, Pa | Voorhees Township | New Jersey | 08043 | United States | ||
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| Atazanavir/Ritonavir + Famotidine | Drug | Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days. |
|
|
| Atazanavir/Ritonavir + Famotidine | Drug | Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days. |
|
|
| Atazanavir/Ritonavir | Drug | Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days. |
|
|
| Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine | Drug | Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days. |
|
|
| Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine | Drug | Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days. |
|
|
| entry and discharge |
| laboratory tests including, liver and renal function | entry, discharge and days 11, 18 |
| CD4 count | discharge |
| HIV viral load | entry and discharge |
| Unc Center For Aids Research |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Local Institution | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution | London | Greater London | SW10 9TH | United Kingdom |
| 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 |
|---|---|
| C000718687 | atazanavir, ritonavir drug combination |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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