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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc (UK-427,857) | Drug | 150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in viral load | Day 11 | |
| UK-427,857 pharmacokinetics | Days 1-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination | Days 1, 11, 40 | |
| 12-lead ECG | Days 1-11 and Day 40 | |
| Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10) |
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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 | Birmingham | Alabama | 35294-2050 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Maraviroc (UK-427,857) | Drug | 100 mg oral tablet once daily while fasted on Days 1-10 |
|
|
| Maraviroc (UK-427,857) | Drug | 300 mg oral tablet once daily while fasted on Days 1-10 |
|
|
| Maraviroc (UK-427,857) | Drug | 150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only) |
|
|
| Placebo | Other | Matching placebo oral tablet on Days 1-10 (fed and fasted) |
|
| Days 1-11 |
| Time course of viral load from baseline to follow-up | Days 1-13 and Days 15, 19, 22, 25, 40 |
| CCR5 receptor saturation | Days 1, 5, 10, 11, 13, 15, 19, 40 |
| Adverse events | Days 1-40 |
| Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90) | Days 1-11 |
| Laboratory safety | Days 1, 3, 7, 11, 15, 40 |
| Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10) | Days 1-11 |
| Supine/standing blood pressure and pulse rate | Days 1-11 and Day 40 |
| Time to rebound of viral load | Days 1-13 and Days 15, 19, 22, 25, 40 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Pfizer Investigational Site | Cologne | 50931 | Germany |
| Pfizer Investigational Site | Frankfurt | 60596 | Germany |
| Pfizer Investigational Site | Hamburg | 20099 | Germany |
| Pfizer Investigational Site | London | NW3 2QG | United Kingdom |
| Pfizer Investigational Site | London | SW10 9NH | 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 |
|---|---|
| D000077592 | Maraviroc |
| 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 |
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