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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00098748 | Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced NonCCR5-Tropic HIV-1 Infected Subjects | PHASE2 | COMPLETED | 190 | — | — | Nov 1, 2004 | Apr 1, 2009 | Dec 7, 2010 | 77 | United States, Australia +7 |
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter \[log10 copies/mL\]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Optimized Background Therapy (OBT) | DRUG | OBT (3-6 drugs based on treatment history and resistance testing) |
| maraviroc (UK-427,857) | DRUG | maraviroc (UK-427,857) 150 mg taken once 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 5,000 copies/mL * Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks * Documented ...