Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVG · 1 trial · 1 indication
| 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...
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EVG is an investigational small molecule being studied for the treatment of HIV Infections and Acquired Immunodeficiency Syndrome. It is developed by Gilead Sciences, Inc. and is currently in Phase 2 clinical development. EVG is intended for use in combination with other antiretroviral agents for HIV-1 infection.
EVG is an integrase inhibitor, targeting the HIV integrase enzyme. By inhibiting this enzyme, EVG is designed to block the integration of viral DNA into the host cell genome, a crucial step in the HIV replication cycle. This mechanism is being evaluated in clinical trials for the treatment of HIV-1 infection.
EVG is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of EVG in patients with HIV Infections and Acquired Immunodeficiency Syndrome.
EVG is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy in treating HIV-1 infection, with completed studies involving adult and adolescent populations.
EVG has been studied in two completed Phase 2 trials. NCT00445146 evaluated the safety of EVG with ritonavir and other antiretrovirals in 192 adults with HIV-1 infection. NCT01721109 assessed the pharmacokinetics, safety, and efficacy of an EVG-containing single tablet regimen in 50 adolescents with HIV.
Yes, EVG is the same as elvitegravir. In clinical trials, EVG is studied as part of combination regimens, such as elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, for the treatment of HIV-1 infection. The drug is being developed by Gilead Sciences, Inc.