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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00708162 | Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir | PHASE3 | COMPLETED | 724 | — | — | Jul 1, 2008 | Apr 1, 2015 | May 30, 2016 | 180 | United States, Australia +12 |
The percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.
| Arm | Type | Description |
|---|---|---|
| Elvitegravir | EXPERIMENTAL | EVG 85 mg or 150 mg + RAL placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their background regimen will receive EVG 85 mg; all other participants will receive EVG 150 mg. |
| Raltegravir | ACTIVE_COMPARATOR | RAL 800 mg (400 mg twice daily) + EVG placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving LPV/r or ATV/r as part of their background regimen in the Open-Label Phase will receive EVG 85 mg; all other participants will receive EVG 150 mg. |
| Name | Type | Description |
|---|---|---|
| Elvitegravir | DRUG | Elvitegravir (EVG) tablet administered orally once daily with food |
| Raltegravir | DRUG | Raltegravir tablet administered orally twice daily according to prescribing information |
| EVG placebo | DRUG | Placebo to match elvitegravir administered orally once daily |
| RAL placebo | DRUG | RAL placebo administered orally twice daily. |
| Background regimen | DRUG | Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV. |
Inclusion Criteria: * Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening * Documented resistance or at least six months experience prior to screening with two or more different classes of antiretroviral agents * Stable antiretroviral regimen for at least 30 days prior to screening: however, par...