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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00363142 | A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects | PHASE3 | COMPLETED | 211 | — | — | May 1, 2006 | Jun 1, 2008 | Nov 5, 2010 | 51 | United States, Puerto Rico |
Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.
| Arm | Type | Description |
|---|---|---|
| FPV/r200 | ACTIVE_COMPARATOR | Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD) |
| FPV/r100 | EXPERIMENTAL | Fosamprenavir/ritonavir 1400/100mg QD |
| Name | Type | Description |
|---|---|---|
| Half-boosted Fosamprenavir | DRUG | Once daily, reduced dose ritonavir-boosted fosamprenavir |
| Full Boosted Fosamprenavir | DRUG | Full ritonavir-boosted fosamprenavir |
Inclusion criteria: * Subjects with HIV-1 infection. * Are willing and able to understand and provide written consent prior to participation in this study. Exclusion criteria: * Are pregnant or breastfeeding. * Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relev...