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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00445146 | Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection | PHASE2 | COMPLETED | 192 | — | — | Feb 1, 2007 | Mar 1, 2015 | Apr 25, 2016 | 48 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| EVG+RTV | EXPERIMENTAL | EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2. |
| Name | Type | Description |
|---|---|---|
| EVG | DRUG | Elvitegravir (EVG) tablet administered orally once daily with food |
| RTV | DRUG | Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food |
| ARV regimen | DRUG | The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval). |
Inclusion Criteria: * Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity. * Males and females of childbearing potential must agree to utilize effective contraception methods. * Ability to understand and sign a written informed consent form. Exclusion Criteria: * Fem...