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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maraviroc | Experimental | Single arm trial looking at the pharmacokinetics of maraviroc in healthy volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Healthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To generate individual maraviroc pharmacokinetic parameters in seminal plasma after single and multiple dosing | Study Days 1, 7, and 8 | |
| To generate composite maraviroc pharmacokinetic parameters in rectal tissue after single and multiple dosing | Study days 1 and 7 or 8 |
| Measure | Description | Time Frame |
|---|---|---|
| To generate matrix:blood plasma ratios of maraviroc in semen and rectal tissue after single and multiple dosing | Days 1, 7 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela DM Kashuba, PharmD | UNC Eshelman School of Pharmacy | Principal Investigator |
| Kristine B Patterson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals CTRC | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21502084 | Derived | Brown KC, Patterson KB, Malone SA, Shaheen NJ, Prince HM, Dumond JB, Spacek MB, Heidt PE, Cohen MS, Kashuba AD. Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis. 2011 May 15;203(10):1484-90. doi: 10.1093/infdis/jir059. |
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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 |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |