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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00959699 | A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4) | PHASE2 | COMPLETED | 99 | — | — | Nov 1, 2009 | Oct 1, 2012 | Apr 7, 2017 | - | — |
SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
| Arm | Type | Description |
|---|---|---|
| PegIFN-2b + RBV | PLACEBO_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| PegIFN-2b + RBV + Boceprevir | ACTIVE_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
| Name | Type | Description |
|---|---|---|
| PegIFN-2b | DRUG | PegIFN-2b (1.5 μg/kg/week subcutaneously) |
| RBV | DRUG | Ribavirin (600-1400 mg/day, orally, divided into two daily doses) |
| Placebo to Boceprevir | DRUG | Placebo to boceprevir (orally, three times per day) |
| Boceprevir | DRUG | Boceprevir (800 mg, orally, three times per day) |
Inclusion Criteria: * \>=18 and \<=65 years of age * Body weight \>=40 and \<=125 kg * Documented history of HIV infection for greater than 6 months prior to Day 1 * On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 \>=200 cells/µL and HIV-1 RNA viral load \<5...