Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elvitegravir · 1 trial · 1 indication
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...
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Elvitegravir is an investigational small molecule being developed for the treatment of HIV infection. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in patients with HIV infection to evaluate its safety and efficacy.
Elvitegravir is an integrase inhibitor, a class of antiretroviral drugs that block the HIV integrase enzyme, preventing the virus from integrating its genetic material into human DNA. This mechanism disrupts the HIV replication cycle and is a key strategy in combination antiretroviral therapy for HIV infection.
Elvitegravir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting the clinical development program for this investigational HIV treatment.
Elvitegravir is in Phase 3 clinical development for the treatment of HIV infection. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 program includes a completed randomized, double-blind, active-controlled study comparing Elvitegravir to Raltegravir.
Elvitegravir has one completed Phase 3 clinical trial, NCT00708162, a multicenter, randomized, double-blind, double-dummy study comparing Elvitegravir versus Raltegravir in 724 patients with HIV infection. The trial was conducted across multiple countries including the United States, Australia, and several European nations.
No, Elvitegravir is not the same as Raltegravir. They are both integrase inhibitors used for HIV treatment, but they are distinct drugs. In clinical trials, Elvitegravir has been directly compared to Raltegravir as an active control to evaluate its relative safety and efficacy.