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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abacavir/Lamivudine | Active Comparator |
| |
| Lersivirine + Abacavir/Lamivudine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir/Lamivudine | Drug | Abacavir/Lamivudine 600/300 mg QD for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine. | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. | 17 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C492871 | abacavir, lamivudine drug combination |
| C531151 | UK 453,061 |
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| Abacavir/Lamivudine |
| Drug |
Abacavir/Lamivudine 600/300 mg QD for 10 days |
|
| Lersivirine | Drug | Lersivirine 750 mg QD for 10 days |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |