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Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | No Intervention |
| |
| A2 | Experimental |
| |
| A3 | Experimental |
| |
| B1 | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nevirapine | Drug | Tablets, Oral, 200 mg, Twice daily, 3 days. |
| |
| Nevirapine + Atazanavir/Ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj. |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi |
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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 | Pomona | California | United States | |||
| Local Institution |
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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 |
|---|---|
| D019829 | Nevirapine |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| C000718687 | atazanavir, ritonavir drug combination |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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| Drug |
Tablets + Capsules/Capsules, Oral, 200 mg + 300/100 mg, twice daily + once daily, 10 days. |
|
|
| Nevirapine + Atazanavir/Ritonavir | Drug | Tablets + Capsules/Capsules, Oral, 200 mg + 400/100 mg, twice daily + once daily, 10 days. |
|
|
| Atazanavir + Ritonavir | Drug | Capsules/capsules, Oral, 300/100 mg, once daily, 10 days. |
|
|
| Seattle |
| Washington |
| United States |
| Local Institution | London | Greater London | United Kingdom |
| 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 |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |