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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00495677 | A Phase 2 Study Of PF-00232798 In HIV Positive Patients | PHASE2 | COMPLETED | 43 | — | — | Jun 1, 2007 | Sep 1, 2008 | Oct 30, 2013 | 2 | Germany |
Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.
| Arm | Type | Description |
|---|---|---|
| PF-00232798 40 mg | ACTIVE_COMPARATOR | - |
| PF-00232798 300 mg | ACTIVE_COMPARATOR | - |
| PF-00232798 400 mg | ACTIVE_COMPARATOR | - |
| PF-00232798 5 mg | ACTIVE_COMPARATOR | - |
| PF-00232798 20 mg | ACTIVE_COMPARATOR | - |
| PF-00232798 150 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-00232798 | DRUG | Solution, 20 mg. once daily, 10 days |
Inclusion Criteria: * Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive. * Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay. Exclusion Criteria: * Patients who have received any experimental drug within the past four months...