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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Twice daily regimen |
|
| Cohort 2 | Experimental | Once daily regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | maraviroc 300 mg BID x 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maraviroc plasma pharmacokinetic parameters: AUCÏ„, Cmax, and CÏ„. | Period 1, Day 5 | |
| Maraviroc plasma pharmacokinetic parameters: AUCÏ„, Cmax, and CÏ„. | Period 2, Day 20 | |
| Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCÏ„, Cmax, and CÏ„. | Period 2, Day 10 | |
| Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCÏ„, Cmax, and CÏ„. | Period 2, Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. | Period 1, Day 5 | |
| Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. | Period 2, Day 20 |
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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 | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Fosamprenavir/ritonavir | Drug | fosamprenavir/ritonavir 700/100 mg BID x 10 days |
|
| Maraviroc + Fosamprenavir/ritonavir | Drug | maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days |
|
| Maraviroc | Drug | maraviroc 300 mg QD x 5 days |
|
| Fosamprenavir/ritonavir | Drug | fosamprenavir/ritonavir 1400/100 mg QD x 10 days |
|
| Maraviroc + Fosamprenavir/ritonavir | Drug | maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days |
|
| Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. | Period 2, Day 10 |
| Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. | Period 2, Day 20 |
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments. | 25 Days |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| C426859 | fosamprenavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
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