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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00098293 | Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine | PHASE3 | COMPLETED | 916 | — | — | Nov 1, 2004 | Dec 1, 2012 | Oct 9, 2013 | 144 | United States, Argentina +12 |
Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 3 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz |
| Name | Type | Description |
|---|---|---|
| Maraviroc + Zidovudine/Lamivudine | DRUG | maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
| Efavirenz + Zidovudine/Lamivudine | DRUG | efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
| Maraviroc (UK-427,857) + Zidovudine/Lamivudine | DRUG | maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) |
Inclusion Criteria: * Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities) * HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL * A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP) * Effec...