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Reformulated Raltegravir · 1 trial · 1 indication
From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
| Arm | Type | Description |
|---|---|---|
| Reformulated Raltegravir | EXPERIMENTAL | Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks |
| Raltegravir | ACTIVE_COMPARATOR | Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks |
| Name | Type | Description |
|---|---|---|
| Reformulated Raltegravir | DRUG | Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily |
| Raltegravir | DRUG | Raltegravir 400 mg tablet orally twice daily |
| TRUVADA™ | DRUG | Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) |
| Placebo to Reformulated Raltegravir | DRUG | Placebo to reformulated raltegravir 2 tablets orally once daily |
| Placebo to Raltegravir | DRUG | Placebo to raltegravir 1 tablet orally twice daily |
Inclusion Criteria: * HIV-1 positive * Naïve to antiretroviral therapy including investigational antiretroviral agents * Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study Exclusion Criter...
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Reformulated Raltegravir is an investigational small molecule being developed for the treatment of HIV Infection. It is a once-daily formulation of raltegravir, an integrase inhibitor, studied in treatment-naive HIV-1 infected adults. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Reformulated Raltegravir works by inhibiting the HIV integrase enzyme, which is essential for viral replication. By blocking this enzyme, the drug prevents the viral DNA from integrating into the host cell's genome, thereby reducing the viral load in infected individuals. This mechanism is shared with the original raltegravir formulation.
Reformulated Raltegravir is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of HIV Infection.
Reformulated Raltegravir is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug is being evaluated for use in treatment-naive HIV-1 infected patients.
Reformulated Raltegravir has one completed Phase 3 clinical trial registered under NCT02131233. This randomized, double-blind, active-controlled study enrolled 802 participants to evaluate the safety and efficacy of reformulated raltegravir 1200 mg once daily in combination with TRUVADA in HIV-1 infected, treatment-naive adults.
Reformulated Raltegravir is a new once-daily formulation of raltegravir, an existing HIV integrase inhibitor. While the active ingredient is the same, the reformulated version is designed to be taken once daily instead of twice daily, potentially improving patient convenience and adherence. It is being studied as a distinct drug product.