Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
raltegravir · 1 trial · 1 indication
To assess AUC, Cmax, Cmin, T 1/2, clearance of RAL at dose of 400 mg BID, 800 mg OD, 400 mg OD in Thai
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | RAL 400 mg OD |
| 2 | ACTIVE_COMPARATOR | RAL 800 mg OD |
| Name | Type | Description |
|---|---|---|
| raltegravir | DRUG | 12 hour PK will be done on day 1 while subjects is on stable regimen with RAL 400 mg BID. After performing intensive PK, subjects will be randomized to either group A (RAL 400 mg OD) or B (RAL 800 mg OD) for 14 days and on day 15, a second 24 hour full PK will be carried out. After the intensive PK, subjects in both the groups will switched to the other dosing regimen, group A (RAL 800 mg OD) and B (RAL 400 mg OD) for another 14 days and on day 29, the third 24 hour full PK will be carried out. |
Inclusion Criteria: * Signed informed consent * Evidence of HIV infection * Age\> 18 years * On RAL 400 mg BID containing HAART regimen with a VL \< 50 copies for at least 3 months before enrollment * Willing to adhere to the protocol requirements Exclusion Criteria: * Evidence of RAL resistance ...
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