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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02131233 | Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) | PHASE3 | COMPLETED | 802 | — | — | May 23, 2014 | Dec 19, 2016 | Jan 30, 2019 | - | — |
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...