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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00454337 | Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load | PHASE3 | COMPLETED | 170 | — | — | May 1, 2007 | Sep 1, 2008 | Apr 6, 2026 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| Intensification arm | EXPERIMENTAL | emtricitabine/TDF + efavirenz or lopinavir/ritonavir + enfuvirtide |
| Standard arm | ACTIVE_COMPARATOR | emtricitabine/TDF + efavirenz or lopinavir/ritonavir |
| Name | Type | Description |
|---|---|---|
| FTC/TDF + EFV or LPV/R +T20 | DRUG | emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day) + enfuvirtide 90mg twice a day |
| FTC/TDF + EFV or LPV/R | DRUG | emtricitabine 200mg/TDF 300mg (1 pill per day) + efavirenz 600mg (1 pill per day) or lopinavir/ritonavir (3 pills twice a day) |
Inclusion Criteria: * Chronic HIV-1 infection * Treatment with a well-tolerated combination of antiretroviral drugs unchanged for at least 3 months, including enfuvirtide * Absence of any uncontrolled opportunistic disease * No restrictions on CD4 lymphocyte levels * Plasma HIV-1 RNA below 400 copi...