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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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Raltegravir is a small molecule being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development, with one completed trial involving 24 participants. The drug is being developed by National Healthcare Corp. and is intended for use in patients with HIV.
Raltegravir is an integrase inhibitor, meaning it targets the HIV integrase enzyme. This enzyme is essential for the viral replication process, as it allows the viral DNA to integrate into the host cell's genome. By inhibiting this enzyme, raltegravir aims to block viral replication.
Raltegravir is being developed by National Healthcare Corp., a company listed under the ticker symbol NHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV Infections.
Raltegravir is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an active-controlled, randomized study. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
Raltegravir has one completed clinical trial registered under NCT01159132, titled "Pharmacokinetics of Low Dose Raltegravir." This Phase 2 study enrolled 24 participants with HIV Infections in Thailand and was active-controlled, though it was not double-blinded.
Raltegravir is also known by the brand name Isentress. It is an integrase inhibitor used in the treatment of HIV Infections. The drug is being developed by National Healthcare Corp. and is currently in Phase 2 clinical trials.