Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01000818 | A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054) | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2008 | Mar 1, 2009 | Mar 21, 2017 | - | — |
Area Under the Plasma Concentration-Time Curve and peak concentration
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | MK0518 |
| Period 2 | EXPERIMENTAL | famotidine + MK0518 |
| Period 3 | EXPERIMENTAL | omeprazole + MK0518 |
| Name | Type | Description |
|---|---|---|
| MK0518 (Raltegravir) | DRUG | 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. |
| famotidine | DRUG | Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518 |
| omeprazole | DRUG | 20 mg oral tablet of omeprazole, once daily for 5 days |
Inclusion Criteria: * Patient is Human immunodeficiency virus (HIV) positive * Patient is taking an MK0518 (Raltegravir) containing regimen * Patient has not had any changes to his/her antiviral regimen in the last 2 weeks * Patient who is of reproductive potential agrees to use an acceptable metho...