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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevirimat 200 mg twice daily, 15 days | Experimental |
| |
| Bevirimat 300 mg once daily, 15 days | Experimental |
| |
| Bevirimat 400 mg once daily, 15 days | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevirimat | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days | 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Beelen, MD | Myrexis Inc. | Study Director |
| Jacob P Lalezari, MD | Quest Clinical Research | Principal Investigator |
| Gary J Richmond, MD, PA | Principal Investigator | |
| Melanie A Thompson, MD | AIDS Research Consortium of Atlanta | Principal Investigator |
| Calvin J Cohen, MD, MSc | Community Research Initiative of New England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Clinical Research | San Francisco | California | 94115 | United States | ||
| Gary J. Richmond, MD, PA |
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| ID | Term |
|---|---|
| C479935 | bevirimat |
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| Fort Lauderdale |
| Florida |
| 33316 |
| United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Community Research Initiative of New England | Boston | Massachusetts | 02215 | United States |